# FDA recall Z-0947-2021

> **Philips Ultrasound Inc** · Class II · device recall initiated 2020-12-24.

## Product

Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi - Product Usage: the systems can assist the interventionist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance.

## Reason for recall

Control panel arm assembly could have missing or loose screws where undue force, pressure or weight is applied, the control panel mechanism can fail and break off.

## Distribution

Worldwide distribution - US Nationwide, Puerto Rico, and Virgin Islands.    O.U.S.:  AE - United Arab Emirates  AL - Albania  AM - Armenia  AR - Argentina  AT - Austria  AU - Australia  AZ - Azerbaijan  BA - Bosnia  BD - Bangladesh  BE - Belgium  BG - Bulgaria  BH - Bahrain  BN - Brunei  BO - Bolivia  BR - Brazil  BY - Belarus  CA - Canada  CH - Switzerland  CL - Chile  CN - China  CO  Colombia  CR  Costa Rica  CY - Cyprus  CZ  Czech Republic  DE - Germany  DK - Denmark  DO  Dominican Republic  DZ - Algeria  EC - Ecuador  EE - Estonia  EG - Egypt  ES - Spain  ET - Ethiopia  FI - Fiji  FR - France  GB  United Kingdom  GF  French Guiana  GP - Guadeloupe  GR - Greece  GT - Guatemala  HK  Hong Kong  HN - Honduras  HR - Croatia  HU - Hungary  ID - Indonesia  IE - Ireland  IL - Israel  IN - India  IR - Iran  IT - Italy  JO - Jordan  JP - Japan  KE - Kenya  KH - Cambodia  KR  South Korea  KW - Kuwait  KZ - Kazakhstan  LB - Lebanon  LK  Sri Lanka  LT - Lithuania  LU - Luxembourg  LV -

## Key facts

- **Recall number:** Z-0947-2021
- **Recalling firm:** Philips Ultrasound Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-24
- **Report date:** 2021-02-10
- **Termination date:** 2023-03-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bothell, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0947-2021

## Citation

> AI Analytics. FDA recall Z-0947-2021. Retrieved 2026-09-27 from https://api.ai-analytics.org/recall/Z-0947-2021. Source: US FDA. Licensed CC0.

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