Zenition 70 — Class II medical device recall Z-0648-2022
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2022-02-23, distributed in AZ, CA, FL, GA, HI, IL, KS, KY…. Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wir
| Recall number | Z-0648-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best, N/A, Netherlands |
| Recall initiated | 2021-12-02 |
| Classified | 2022-02-17 |
| Reported by FDA | 2022-02-23 |
| Distributed | 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 |
| Reason classes | software |
| Model numbers | 718133 |
Product
Zenition 70, Model #718133
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0648-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.