# FDA recall Z-0648-2022

> **PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.** · Class II · device recall initiated 2021-12-02.

## 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.

## 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.

## Key facts

- **Recall number:** Z-0648-2022
- **Recalling firm:** PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-12-02
- **Report date:** 2022-02-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Best, N/A, Netherlands

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0648-2022

## Citation

> AI Analytics. FDA recall Z-0648-2022. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-0648-2022. Source: US FDA. Licensed CC0.

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