Recall Z-1053-2024 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Maquet Medical Systems USA
Bubble Sensor (REF: 70105.5720)
| Date | Feb 8, 2024 (initiated Dec 28, 2023) |
| Status | Open, Classified |
| Reason | The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device. |
| Root cause | Labeling mix-ups |
| Action | An Urgent Medical Device Correction Letter was sent VIA Fed-Ex 2-day delivery with signature proof of delivery to all consignees with the following instructions: Actions to be taken by the Customer: - Please examine your inventory immediately to determine if you have any affected product in your inventory. - Whether or not your facility has affected product(s) listed in this notice, please complete and sign the attached MEDICAL DEVICE - CORRECTION RESPONSE FORM to acknowledge that you have received this notification. Return the completed form to Getinge by e-mailing a scanned copy to BubbleSe |
| Quantity | 274 units (70 US, 204 OUS) |
| Distribution | AZ, CA, CO, FL, GA, IA, IL, MN, NE, PA, TX, WA and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133598 | CARDIOHELP SYSTEM Maquet Cardiopulmonary, AG, May 21, 2014 |