Recall Z-0648-2022 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Zenition 70, Model #718133
| Date | Dec 2, 2021 |
| Status | Open, Classified |
| Reason | Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system. |
| Root cause | Under Investigation by firm |
| Action | On December 2, 2021, the firm issued Urgent Medical Device Correction letters to affected customers. The Medical Device Correction includes the following instructions for the Customer: o Ensure that the wired foot switch is always connected to the system. o Immediately start using the wired foot switch or hand switch in the event the wireless foot switch loses connection. o Perform a daily check for damage and correct functioning of the hand switch and wired foot switch as described by the User Routine Checks section in your Instruction for Use. o Circulate this notice to all users o |
| Quantity | 95 US; 284 ROW |
| Distribution | Domestic distribution to AZ CA FL GA HI IL KS KY MA MD ME MI MN MS NC NE NJ NV NY OH PA TN TX VA WA WV. Worldwide foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183040 | Zenition 70 Philips Medical Systems Nederland B.V., Dec 6, 2018 |