PlainRecalls
FDA Devices Verify with FDA Devices → Moderate Class II Terminated

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.

Reported: February 10, 2021 Initiated: December 24, 2020 #Z-0947-2021 12,080 systems units

Philips Ultrasound Inc issued this FDA Devices recall on February 10, 2021. Classified as Moderate severity (Class II). Approximately 12,080 systems units are affected. The recall was issued because: Control panel arm assembly could have missing or loose screws where undue force, pressure or weight is applied, the con…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

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 indicate 12,080 systems units are affected.

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.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 5 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity1Class I (Critical)Class II (Moderate)Class III (Low)
Recall Distribution by Severity Class

Severity

Moderate

Units Affected

12,080 systems

Related Recalls

6

6 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.

Details

Recalling Firm
Philips Ultrasound Inc
Units Affected
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 - 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
Location
Bothell, WA

Recall Profile

Structured summary of the FDA Devices recall record
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
Units affected 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.

Scale of Impact

12,080 systems units affected — limited or regional distribution scale.

Regional (<10K units) —
Multi-state (10K – 100K units) ✓ This recall
Large-scale (100K – 1M units) —
Massive (≥1M units) —

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

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.

Recall Guides

Learn how the US recall system works and how to protect yourself and your household.

How the US Recall System Works

The three federal agencies, how recalls are initiated, and what happens next.

Understanding Recall Severity Classes

What Class I, II, and III mean and which recalls demand immediate action.

What to Do When a Product Is Recalled

Verify, claim your remedy, report injuries, and navigate the process.

How to Check If Your Products Are Recalled

Step-by-step guide to checking food, products, medications, and vehicles.

Recalled Products in Your Home

A room-by-room household audit guide for active recalls.

Most Recalled Product Categories

Rankings of highest-recall categories from FDA, CPSC, and NHTSA.

Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

Related Safety Data

Explore related product safety and public health data from federal sources.

Food Safety Inspections

FDA and state food facility inspection results — violations, enforcement actions, and compliance history for food manufacturers and processors.

PlainFoodSafe →

Ingredient Safety Data

FDA food additive and ingredient safety database — regulatory status, usage limits, and safety assessments for thousands of ingredients.

PlainIngredients →

Nutrition Data

USDA nutrition facts for 2M+ food items — calories, macros, vitamins, and ingredient analysis to verify what you consume.

GetFoodFacts →

Drug Safety Information

FDA drug data for 680+ medications — interactions, alternatives, side effects, and safety information for recalled and active drugs.

PlainMeds →

Product Injury Data

CPSC emergency room injury data for 838 product categories — 7.3M NEISS records tracking real-world consumer product injuries.

PlainSafety →

Recall Checker

Search our database of 83K+ recalls by product name, brand, or recall number across all agencies.

Check Now →

Recall Radar

Live feed of the latest recalls across FDA, CPSC, NHTSA, and USDA — filter by agency and severity.

View Radar →

Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

FDA Devices Moderate

Endo-Model Replacement Plateau; Item Number: 15-0027/11;

Waldemar Link GmbH & Co. KG (Mfg Site) · 2026-03-18
FDA Devices Low

Penner Pacific Bathing Spa, Model Numbers 360020-1P

Penner Patient Care, Inc. · 2026-03-18
FDA Devices Moderate

GEM Premier 5000 PAK, Part No. 00055360004.

Instrumentation Laboratory · 2026-03-18
FDA Devices Moderate

CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281

Beckman Coulter Mishima K.K. · 2026-03-18
FDA Devices Critical

Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Descript…

Trividia Health, Inc. · 2026-03-18

Compare this recall with Endo-Model Replacement Plateau; Item Number: 15-0027/11; →

Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
  • Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Read our methodology — how this data is sourced, computed, and verified.

All federal data sources used on this page

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).