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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
Medical Devices/Diagnostic Equipment

Philips North America: BrightView Gamma Camera Systems Recalled for Entrapment Hazard

Agency Publication Date: January 5, 2024
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Summary

Philips North America is recalling 553 BrightView Gamma Camera Systems because a gap can form between the patient support and the detector during certain automated scans. This defect can cause parts of a patient's body to become trapped while the machine is in motion. The recall includes BrightView, BrightView X, and BrightView XCT models distributed across the United States and internationally. Consumers should contact their healthcare provider or Philips to ensure their system is inspected or repaired.

Risk

A gap created during extrinsic quality assurance scans presents a serious entrapment hazard. This can lead to severe injuries including bone fractures, crush injuries, lacerations, or the permanent loss of function in an extremity if a patient's limb becomes caught in the machinery.

What You Should Do

  1. Identify if your facility uses a Philips BrightView, BrightView X, or BrightView XCT Gamma Camera System by checking the model name on the device or service records.
  2. Check the serial number of your device against the affected list. For BrightView (Product Code 882480), affected serials include 4000002, 4000262, 4000681, and hundreds of others listed in the recall notice.
  3. For BrightView X (Product Code 882478), check for serial numbers such as 11000072, 11000116, and 11000007.
  4. For BrightView XCT (Product Code 882482), check for serial numbers such as 7811_12, 6000374, and 6000199.
  5. Contact Philips North America or your healthcare provider immediately to discuss safety precautions and to schedule any necessary software or mechanical fixes.
  6. If you have questions regarding this recall, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

System maintenance or modification

How to: Contact your healthcare provider or the manufacturer (Philips North America) for further instructions and potential remedy or modification for the entrapment hazard.

Affected Products

Product: BrightView Gamma Camera System
Model / REF:
Product Code 882480
Recall #: Z-0677-2024
Lot Numbers (685):
4000002
4000262
4000681
4000218
4000413
4000312
4000389
4000678
4000484
4000288
4000393
4000494
4000354
4000699
4000515
4000679
4000479
4000689
4000082
4000373
4000471
4000545
4000331
4000038
4000060
4000161
4000164
4000360
4000175
4000244
4000186
4000242
4000235
4000255
4000247
4000320
4000347
4000367
4000402
4000430
4000473
4000591
4000537
4000505
4000529
4000524
4000562
4000582
4000606
4000583
Product: BrightView X Gamma Camera
Model / REF:
Product Code 882478
Recall #: Z-0678-2024
Lot Numbers (118):
11000072
11000116
11000007
11000010
11340001
11000027
11000032
4000570
11000041
11000092
11000113
11340003
11000044
11000006
11000033
11000025
11000105
11000016
11000003
11000018
11000065
11000047
11000066
11000101
11000107
11000090
11000029
11000056
11000026
11000046
11000051
11000078
11000114
11000067
11000050
11000084
11000068
11000052
11000057
11000055
11000070
11000088
11000023
11000061
11000060
11000095
11000094
11000102
11000054
11340004
Product: BrightView XCT Gamma Camera
Model / REF:
Product Code 882482
Recall #: Z-0679-2024
Lot Numbers (429):
7811_12
6000374
6000199
6000219
6000012
6000123
6000065
6000051
6000084
6000351
6000259
6000212
6000337
6000302
6000144
6000193
6000068
6000075
6000385
6000027
6000124
600009
6000176
6000260
6000298
6000189
6000040
6000140
6000146
6000197
6000408
6000401
6000104
6000289
6000306
6000304
6000022
6000015
6000163
11000021
6000325
6000021
6000056
6000060
6000057
6000026
6000054
6000033
6000089
6000094

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93643
Status: Active
Manufacturer: Philips North America
Sold By: Authorized Medical Equipment Distributors; Direct Sales to Medical Facilities
Manufactured In: United States
Units Affected: 3 products (359 US; 328 OUS; 59 US; 59 OUS; 135 US; 294 OUS)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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 ยท 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.