Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 10, 2021
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.
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips Ultrasound Inc recalled Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, … - a moderate-severity action.
Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, … was recalled by Philips Ultrasound Inc in February 10, 2021. Reason: Control panel arm assembly could have missing or loose screws where undue force, pressure or weight is applie…. Check the official notice for the remedy. Verify recall #Z-0947-2021 with the FDA Devices before acting.
The recall
Philips Ultrasound Inc issued this moderate-severity FDA Devices recall-Control panel arm assembly could have missing or loose screws where undue force, pressure or weight is applie….
- Moderate
- severity level
- Class II
- classification
- February 10, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0947-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0947-2021) was formally reported on February 10, 2021, with the manufacturer initiating the action on December 24, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Philips Ultrasound Inc is listed as the recalling firm, operating out of Bothell, WA. Federal records list the affected scope as 12,080 systems.
The documented reason for this recall is: 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 data in the federal record shows the product reached: 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 …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
12,080 systems
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0947-2021 |
| Date reported | February 10, 2021 |
| Date initiated | December 24, 2020 |
| Recalling firm | Philips Ultrasound Inc |
| Firm location | Bothell, WA |
| Affected scope | 12,080 systems |
| 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 - B… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0947-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Philips Ultrasound Inc. Units affected: 12,080 systems.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 10, 2021. Severity: Moderate. Recall number: Z-0947-2021.
Where was the recalled product distributed? ▼
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 - Latvia LY - Libyan MA - Morocco MC - Monaco MD Republic of Moldova ME - Montenegro MM - Myanmar MO - Macau MQ - Martinique MT - Malta MU Mauritius MX Mexico MY Malaysia NC New Caledonia NI - Nicaragua NL - Netherlands NO - Norway NZ New Zealand OM - Oman PA - Panama PE - Peru PF French Polynesia PH - Philippines PK - Pakistan PL - Poland PS - Palestinian PT - Portugal QA - Qatar RE - Reunion RO - Romania RS - Serbia RU - Russia SA Saudi Arabia SE - Sweden SG - Singapore SI - Slovenia SK - Slovakia TH - Thailand TM - Turkmenistan TN - Tunisia TR - Turkey TT - Trinidad TW - Taiwan UA - Ukraine UY - Uruguay UZ - Uzbekistan VN - Vietnam ZA South Africa.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0947-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 10, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.