Getinge Usa Sales Inc: Meera Mobile Operating Table Recalled for Unintended Movement Risk

Agency Publication Date: October 4, 2023

Summary

Getinge USA Sales Inc. is recalling 224 Meera Mobile Operating Tables because a specific sequence of commands on the control unit can trigger an unintended movement (autodrive) for up to 7 seconds. This mobile table is used to support and position patients before, during, and after surgical procedures or treatments. This malfunction could cause the table to move unexpectedly while a patient is being positioned or treated, which may lead to patient or staff injury.

Risk

The device's traction drive may activate unexpectedly due to a software or command sequence error, causing the heavy operating table to move on its own for up to 7 seconds. This uncontrolled movement poses a risk of crushing, falling, or collision injuries to patients undergoing surgery or to the medical staff operating the equipment.

What You Should Do

Identify if your facility has the Meera Mobile Operating Table by checking for Model Number 7200.01F2 and UDI Code 04046768124363.
Verify the serial number on the device's identification plate; affected serial numbers include: 7, 9, 10, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 42, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 56, 57, 59, 60, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 110, 111, 112, 113, 114, 115, 116, 118, 119, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 134, 135, 137, 138, 139, 140, 141, 142, 143, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 185, 186, 188, 189, 190, 192, 193, 194, 195, 196, 502, 503, 504, 505, 506, 507, 508, 509, 510, 511, 512, 513, 514, 516, 518, 519, 520, 521, 523, 524, 527, 532, 533, 534, 535, 536, 537, 538, 539, 540, 541, 544, 545, 546, 547, 548, 549, 550, 551, 553, 554, 555, 556, 557, 558, 561, 563, 564, 565, 566, 567, 569, 571, 572, 573, 579, 580, 581, 583, 584, 585, 586, 587, 588, and 589.
If you own an affected table, contact your healthcare provider or Getinge USA Sales Inc. immediately to understand the necessary safety precautions or software updates required.
Follow any specific instructions provided in the firm's notification letter sent on September 6, 2023.
For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer initiated contact via letter.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Meera Mobile Operating Table

Model / REF:

7200.01F2

UPC Codes:

04046768124363

Lot Numbers:

04046768124363

Serial Numbers: 7 10 9 18 16 14 15 17 13 24 21 22 23 20 25 19 26 32 28 29 30 31 27 42 44 45 46 47 48 49 50 51 54 59 60 52 53 56 57 63 67 74 64 68 72 73 65 69 70 71 66 75 77 78 80 81 82 79 89 83 84 85 86 87 88 90 91 93 92 94 95 96 104 105 99 101 100 102 98 106 107 108 97 103 113 111 112 114 115 119 110 116 118 125 127 128 132 129 130 131 123 124 126 138 134 135 137 139 141 142 143 140 154 146 156 145 147 149 148 150 151 155 161 165 166 164 167 169 171 170 157 162 159 158 163 168 172 174 175 178 179 176 177 152 153 180 181 183 185 182 186 193 196 188 195 189 192 194 190 502 503 504 505 506 507 510 508 509 511 512 513 514 516 520 524 523 521 527 518 519 534 535 536 532 533 541 538 539 537 540 544 545 546 547 548 549 553 550 551 554 555 557 558 556 561 563 564 565 566 569 571 572 567 573 581 579 580 583 585 586 587 584 588 589

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93005

Status: Active

Manufacturer: Getinge Usa Sales Inc

Sold By: Authorized Getinge medical equipment distributors; Direct sales to hospitals and surgical centers

Manufactured In: United States

Units Affected: 224 units

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 · 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.

Summary

Risk

What You Should Do

Identify if your facility has the Meera Mobile Operating Table by checking for Model Number 7200.01F2 and UDI Code 04046768124363.

Verify the serial number on the device's identification plate; affected serial numbers include: 7, 9, 10, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 42, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 56, 57, 59, 60, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 110, 111, 112, 113, 114, 115, 116, 118, 119, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 134, 135, 137, 138, 139, 140, 141, 142, 143, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 185, 186, 188, 189, 190, 192, 193, 194, 195, 196, 502, 503, 504, 505, 506, 507, 508, 509, 510, 511, 512, 513, 514, 516, 518, 519, 520, 521, 523, 524, 527, 532, 533, 534, 535, 536, 537, 538, 539, 540, 541, 544, 545, 546, 547, 548, 549, 550, 551, 553, 554, 555, 556, 557, 558, 561, 563, 564, 565, 566, 567, 569, 571, 572, 573, 579, 580, 581, 583, 584, 585, 586, 587, 588, and 589.

If you own an affected table, contact your healthcare provider or Getinge USA Sales Inc. immediately to understand the necessary safety precautions or software updates required.

Follow any specific instructions provided in the firm's notification letter sent on September 6, 2023.

For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: Meera Mobile Operating Table

Model / REF:

7200.01F2

UPC Codes:

04046768124363

Lot Numbers:

04046768124363