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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Philips Medical Systems (Cleveland) Inc: An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.

Agency Publication Date: July 22, 2019
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Affected Products

Product: BrightView SPECT, Model Number 882480

Serial Numbers: 4000665 4000410 4000652 4000651 4000350 4000688 4000224 4000065 4000321 4000002.75 4000044 4000081 4000061 4000180 4000298 4000280 4000229 4000262 4000552 4000378 4000559 4000324 4000576 4000184 4000190 4000516 4000554 4000627 4000566 4000303 4000614 4000411 4000669 4000009 4000305 4000612 4000681 4000301-1 4000202 4000008 4000218 4000166 4000033 4000455 4000287 4000091 4000497 4000498 4000102 4000276 4000123 4000364 4000070 4000699 40000699 4000213 4000012 4000413 4000335 4000197 4000571 4000436 4000648 4000617 4000581 4000500 4000544 4000592 4000491 4000510 4000518 4000472A 4000555 4000454 4000418 4000353 4000469 4000005 4000042 4000379 4000451 4000533 4000602 4000343 4000540 4000547 4000682 4000317 4000338 4000316 4000342 4000408 4000421 4000495 4000511 4000664 4000604 458008 4000647 4000341 4000328 4000375 4000483 4000346 4000683 4000550 4000487 4000039 4000601 4000067 4000068 4000301 4000031 4000560 4000283 4000045 4000129 4000032 4000312 4000422 4000366 4000372 4000381 4000051 4000003 4000071 4000557 4000336 4000620 4000567 4000678 4000057 4000057-OLD 4000006 4000423 4000223 4000056 4000197_1 4000122 4000549 4000417 4000466 4000151 4000389 4000536 4000370 4000088 4000290 4000158 4000029 4000607 4000672 4000286 4000395 4000294 4000348 4000613 4000655 4000390 4000419 4000462 4000463 4000464 4000638 422 281 199 288 4000096 4000281 4000288 4000484 4340005 97001 4000273 4000268 4000382 4000169 4000447 4000595 4000692 4000693 4000228 4000442 4000047 4000049 4000156 4000412 4000297 4000488 4000337 4000600 4000585 4000109 4000115 4000504 4000631 4000494 4000356 4000503 4000194 4000386 4000179 4000401 4000385 4000397 4000667 4000121 4000257 4000398 4000400 4000105 4000333 4000339 4000107 4000227 4000233 4000173 4000168 4000256 4000698 4000126 4000154 4000399 4000072 4000237 4000493 4000354 4000296 4000272 4000478 4340004 4000643 4000694 4000376 4000219 4000243 4000437 4000416 4000485 4000035 4000645 4000551 4000427 4000548 4000691 6000046 4000475 4000142 4000226 4000519 4000066 4000183 4000461 4000063 4000210 4000394 4000459 4000468 4000150 4000201 4000217 4000530 4000640 4000420 4000572 4000573 4000639 4000479 4000568 4000690 4000689 4000300 4000392 4000086 4000080 4000013 4000396 4000481 4000075 4000157 4000428 4000374 4000543 4000167 4000041 4000203 4000407 4000621 4000676 4000299 4000133 4000209 4000477 4000314 4000675 4000686 4000010 4000539 4000663 4000637 4000409 4000134 4000373 4000471 4000545 4000163 4000465 4000153 4000618 4000641 1119-07 1379-04 1406-37 4000082 4000331 4000282 4000679 7135_11 4000449 4000216 4000269 4000415 4000345 4000208 4000254 4000125 4000279 4000624 4000307 4000453 4000525 4000541 4000289 4000087 4000204 4000322 4000011 4000403 4000277 4000323 4000232 4000668 4000160 4000036 4000116 4000406 4000489 4000161 4000434 4000048 4000241 4000177 4000191 4000448 4000597 4000171 4000094 4000030 400054 4000470 4000059 4000064 4000590 4000104 4000292 4000524 4000630 4000141 4000361 4000606 4000117 4000623 4000138 4000239 40007060008 4000176 4000404 4000139 4000207 4000055 4000248 4000358 4000642 4000146 4000159 4000284 4000537 4000591 4000558 4000188 4000528 4000697 4000486 4000450 4000509 4000225 40007060007 4000124 4000432 4000362 4000259 4000569 4000696 4000388 4000433 4000178 4000143 4000377 4000369 4000383 4000431 4000164 4000588 4000473 4000120 4000563 4000587 4000583 4000619 4000357 4000313 4000340 4000628 4000521 4000093 4000258 4000330 4000108 4000501 4000611 4000060 4000004 4000264 4000534 4000145 4000657 4000659 4000099 4000192 4000249 4000564 4000291 4000002 4000040 4000306 4000332 4000193 4000222 4000079 4000234 4000090 40000101 4000106 4000144 4000127 4000594 4000205 4000250 4000380 4000520 4000325 4000443 4000135 4000189 4000058 4000310 4000538 4000507 4000561 4000128 4000214 4000212 4000562 4000384 4000556 4000629 4000523 4000240 4000684 4000285 4000496 4000579 4000546 4000111 4000610 4000054 4000110 4000653 4000149 4000076 4000311 4000677 4000529 4000050 4000155 4000429 4000649 4000526 4000626 4000636 4000326 4000622 4000349 4000658 4000308 4000319 4000574 4000132 4000236 4000246 4000187 4000206 4000215 4000661 4000535 4000425 4000100 4000674 4000151-1 4000119 4000231 4000351 4000278 4000582 4000130 4000506 4000185 4000275 4000344 4000309 400438 4000220 4000632 4000103 4000695 4000270 4000625 4000615 4000484A 4000598 4000646 4000274 4000253 4000666 4000034 4000460 4000359 4000263 4000182 4000074 4000265 4000255 4000633 4000593 4000580 4000112 4000352 40007060006 4000532 4000635 4000053 4000476 4000662 4000650 4000575 4000654 4000656 4000098A 4000414 4000251 4000474 4000446 4000046 4000315 4000444 4000660 4000247 4000531 4000302 4000634 4000238 4000680 4000293 4000095 4000609 4000616 4000424 4000508 4000148 4000603 4000565 4000577 4000266 4000578 4000347 4000368 4000318 4000505 4000007 4000113 4000073 4000405 4000517 4000441 4000439 4000542 4000644 4000062 4000136 4000089 4000703001 4000140 40000092 4000467 4000687 4000430 4000673 4000502 4000083 4000367 4000114 4000685 4000186 4000038 4000077 4000320 4000387 4000152 4000235 4000242 4000043 4000137 4000267 4000198 4000499 4000271 4000589 4000221 4000037 40007050005 4000200 4000456 4000327 4000181 4000492 4000165 4000252 4000371 4000513 4000435 4000596 4000426 4000440 4000196 4000363 4000230 4000599 4000605 4000260 4000391 4000482 4000244 4000162 4000402 4000304 4000052 4000445 4000118 4000355 4000261 4000522 4000584 4000671 4000078 4000174 4000490 4000553 4000480 4000334 4000245 4000295 4000452 4000586 4000360 4000170 4000670 4000608 4000329 4000175 4000527 4000199 4000211 10422 4000515 4000393

Product: BrightView X , Model Number 882478

Serial Numbers: 11000044 11000006 11000033 11000025 11000105 11000016 11000072 11000116 11000101 11000065 11000047 11000018 11000003 11000066 11000078 11000046 11000051 11000114 11000026 11000032 11340001 11000007 11000010 11000027 11000084 11000088 11000057 11000052 11000055 11000068 11000050 11000067 11000070 11000095 11000023 11000102 11000060 11000061 11000094 11000054 11340004 11000091 11000098 11000083 11000063 11000013 11000015 11000062 11000081 11000035 11000009 11000110 11000017 11000090 11000107 11340003 11000056 11000029 11000092 11000041 11000042 11000020 11000109 11000008 11000011 11000039 11000087 11000100 11000093 11000079 11000080 11000074 11000005 11000071 11000043 11000049 11000089 11000030 11000037 11000014 11000104 11000038 11000106 11340002 11000085 11000108 11000040 11000059 11000112 11000045 11000076 11000028 11000113 11000117 11000103 11000069 11000012 11000075 11000004 11000096 11000097 11000048 11000058 11000118 11000086 11000077 11000036 11340005 11000064 11000022 11000031 11000073 11000024 11000019 11000099 11000034 11000115

Product: BrightView XCT , Model Number 882482

Serial Numbers: 6000241 6000290 6000291 6000292 6000306 6000289 6000304 6000374 6000318 6000219 6000054 6000089 6000194 6000165 6000199 6000171 6000053 6000352 6000203 6000396 6000094 6000229 6000391 6000033 6000060 6000220 6000057 6000164 6000167 6000195 6000204 6000235 6000043 6000082 6000295 6000402 6000056 6000237 6000355 6000349 6000317 6000021 6000206 6000026 6000228 6000015 6000163 11000021 6000325 6000022 6000210 6000338 6000012 6000037 6000269 6000047 6000330 6000184 6000128 6000132 6000251 6000310 6000309 6000416 6000077 6000130 6000339 6000066 6000131 6000020 6000147 6000123 6000115 6000126 6000276 6000109 6000081 6000083 6000086 6000246 6000332 6000201 6000036 6000187 6000051 6000351 6000185 6000188 6000084 6000127 6000070 6000183 6000006 6000038 6000045 6000065 6000074 6000380 6000234 6000159 6000334 6000296 6000174 6000173 6000182 6000013 6000113 6000090 6000072 6000078 6000368 6000370 6000025 6000029 6000215 6000186 6000236 6000363 6000406 6000240 6000145 6000212 6000407 6000389 6000233 6000129 6000121 6000303 6000333 6000319 6000271 6000342 6000211 6000367 6000224 6000156 6000300 6000320 6000041 6000262 6000293 6000307 6000329 6000354 6000216 6000255 11000082 6000274 6000227 6000064 6000248 6000400 6000384 6000101 6000062 6000398 6000100 6000238 6000133 6000190 6000010 6000337 6000105 6000336 6000202 6000371 6000049 6000181 6000103 6000265 6000222 6000032 6000346 6000321 6000226 6000141 6000067 6000068 6000075 6000273 6000365 6000362 6000168 6000418 6000125 6000166 6000169 6000359 6000427 6000205 6000280 6000281 6000048 6000055 6000061 6000341 6000358 6000350 6000421 6000157 6000326 6000155 6000249 6000044 6000315 6000120 6000385 5340007 6000193 6000099 6000299 6000027 6000079 6000017 6000139 6000247 6000426 6000410 6000102 6340008 6000347 6000176 6000414 6340010 6000305 6000039 6000252 6000264 6000260 6000294 6000343 6000268 6000323 6000392 6000428 6000267 6000223 6000425 6000423 6000424 6000298 6000138 6000154 6000242 6000243 6000314 6000413 6000050 6000297 6000207 6000230 6000098 6000144 6000254 6000257 6000270 6000096 6000302 6000357 6000328 6000200 6000258 6000376 6000192 6000059 6000097 6000379 6000111 6000005 6000259 6000278 6000035 6000375 6000221 6000119 6000282 6000415 6000261 7811_12 6000104 6000231 6000136 6000151 6000180 6000369 6000118 6000080 6000088 6000085 6000244 6000073 6000381 6000393 6000411 6000069 6000011 6000076 6000018 6000092 6000095 6000403 6000313 6000052 6000031 6000107 6000405 6000042 6000153 6000383 6000143 6000117 6000364 6000422 6000160 6000308 6000285 6000112 6000312 6000135 6000172 6000178 6000372 6000019 6000284 6000142 6000340 6000404 6000327 6000198 6000214 6000373 6000387 6000253 6000316 6000063 6000344 6000040 6000394 6000395 6000283 6000377 6000217 6000388 6000146 6000232 6000239 6000058 6000179 6340009 6000335 6000356 6000024 6000140 6000408 6000401 6340011 6000348 6000189 6000134 6000158 6000208 6000209 6000266 6000286 6000108 6000016 6000277 6000245 6000419 6000177 6000279 6000322 6000250 6000263 6000324 6000399 6000409 6000331 6000028 6000390 6000170 6000116 6000023 6000091 6000420 6000353 6000149 6000378 6000003 6000071 6000386 6000087 6000345 6000197 6000004A 6000114 6000150 6000148 6000122 6000360 6000366 6000106 6000272 6000110 6000196 6000152 6000218 6000030 6000382 11000111 6000287 6000004 6000005A 6000361 6000412 6000161 6000225 6000175 6000288 6000275 6000417 6000002 6000162 6000311 6000191 6000213 6000301

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83201
Status: Resolved
Manufacturer: Philips Medical Systems (Cleveland) Inc
Manufactured In: United States
Units Affected: 3 products (696; 117; 427)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.