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U.S. Department of Health and Human Services

Class 2 Device Recall Meera Mobile Operating Table

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 Class 2 Device Recall Meera Mobile Operating Tablesee related information
Date Initiated by FirmSeptember 06, 2023
Date PostedOctober 04, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0036-2024
Recall Event ID 93005
Product Classification Table, operating-room, ac-powered - Product Code FQO
ProductMeera 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
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
FEI Number 3013876692
Recalling Firm/
Manufacturer		 Getinge Usa Sales Inc
1 Geoffrey Way
Wayne NJ 07470-2035
Manufacturer 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
FDA Determined
Cause 2		Software Manufacturing/Software Deployment
ActionMaquet GMBH / Getinge initiated Urgent Medical Device Correction letter on 9/6/23 via Fed'X. Letter states reason for recall, health risk and action to take: Please examine your inventory immediately to determine if you have any of the Meera Mobile Operating Table with the serial numbers listed in this notice. Maintain awareness on this notice and related actions until your operating table has been updated to ensure effectiveness of the corrective action. Please complete and sign the attached MEDICAL DEVICE CORRECTION- RESPONSE FORM (page 4) to acknowledge that you have received this notification. Return the completed form to Maquet/Getinge by e-mailing a scanned copy to meera-unintendedmovement2023.sw.qrc@getinge.com or by faxing the form to 800-746-3592 Please forward this information to all current and potential Meera Mobile Operating Table users within your hospital / facility. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. Getinge has developed a correction to address this issue. A Getinge Service representative will contact you to schedule the correction. This work will be done at no cost to your facility. If you have any questions, please contact your Maquet /Getinge representative Getinge Technical Support at (888) 943-8872 (press option 4, then option 2, then option 1) Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
Quantity in Commerce224 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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