Meera Mobile Operating Table-to support and position the patient immediately before, during and a...
FDA Device Recall #Z-0036-2024 — Class II — September 6, 2023
Recall Summary
| Recall Number | Z-0036-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 6, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Getinge Usa Sales Inc |
| Location | Wayne, NJ |
| Product Type | Devices |
| Quantity | 224 units |
Product Description
Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F2
Reason for Recall
Under certain conditions, an issue might prevent the device from performing as intended. A specific sequence of commands on the control unit activates the traction drive and triggers an unintended driving (autodrive) of max. 7 sec. may result in the following reasonably foreseeable injury or damage to the health of patients and/or users
Distribution Pattern
US Nationwide distribution.
Lot / Code Information
UDI Code: 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
Other Recalls from Getinge Usa Sales Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1074-2025 | Class I | Vaporizer Sevoflurane, Quik-Fil. Model Number: ... | Jan 15, 2025 |
| Z-0462-2025 | Class II | MEERA CL mobile operating table - Designed for ... | Oct 3, 2024 |
| Z-0463-2025 | Class II | MEERA CL mobile operating table - Designed for ... | Oct 3, 2024 |
| Z-0458-2025 | Class II | MEERA CL mobile operating table - Designed for ... | Oct 3, 2024 |
| Z-0460-2025 | Class II | MEERA CL mobile operating table - Designed for ... | Oct 3, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.