FDA Device recall Z-0647-2022
Zenition 50, Model #718096
- FDA Device
- Class II
- ongoing
- Published 2022-02-23
On 2022-02-23 the FDA classified a Class II recall of Zenition 50, Model #718096 by Philips Medical Systems Nederland B V, citing 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 pr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0647-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-12-02 |
| Published | 2022-02-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | 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 |
Product
Zenition 50, Model #718096
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.
Identifiers
| code_info | Wireless Foot switch 3P : 459801238191 Wireless Foot switch 3P: 459801238231 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0647-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.