Recall Z-0902-2013 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Salyer Prn Biomedical
Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.
| Date | Mar 1, 2013 (initiated Jan 31, 2013) |
| Status | Terminated |
| Reason | Concerns that the addition of the UPS Battery Backup to the Century Console Base Shelf did not comply with the FDA premarket notification regulations. |
| Root cause | No Marketing Application |
| Action | An Urgent: Medical Device Recall letter, dated 1/31/13, was sent to all the customers that received the Century Console Base Shelf option with the Linear/1.5k 115v UPS Battery Backup for the Century Heart Lung Machine. The letter informed the customers that Salyer PRN Biomedical will have a Salyer Biomedical technician return the customers' Century Console Bases to their original configuration without the Shelf option and restore the Linear/1.5k UPS Battery Backup to its original condition as a stand-alone unit with its own wheel base for ease of use. A refund or credit will be issued for th |
| Quantity | 9 units |
| Distribution | Distributed in the states of MA,CA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.