# FDA recall Z-0476-2022

> **Philips North America Llc** · Class II · device recall initiated 2021-10-29.

## Product

Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray System .  Model Number: 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722036, 722038, 722039, 722058, 722059, 722065, 722066, 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228.    Wireless footswitch Models: 459801319471, 459801319521, 459801319361, 459801319421, 459801319481, 459801319531, 459801319511, 459801319541, 459801319371, 459801319431, 459801319391, 459801319441, 459801238241, 459801238231, 459801238261, 459801238251, 459801238201, 459801238191, 459801238221, 459801238211, 459801733051, 459801733061, 459801733071, 459801733081, 459801257861, 459801733091

## Reason for recall

Wireless foot switch connection issues causing interruption of Fluoroscopy and exposure

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Australia, Austria,  Bangladesh, Belgium, Chile, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Korea, Republic of Kuwait,  Latvia, Lebanon, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan,  Palestine, State of Philippines, Poland, Portugal, R¿union, Romania, RUMANIA,  Russian Federation,  Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa,  Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, UZBEKISTAN, Viet Nam.

## Key facts

- **Recall number:** Z-0476-2022
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-10-29
- **Report date:** 2022-01-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cambridge, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0476-2022

## Citation

> AI Analytics. FDA recall Z-0476-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0476-2022. Source: US FDA. Licensed CC0.

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