Philips Ultrasound Inc

Complete recall history across all FDA and CPSC categories — 14 total recalls

Philips Ultrasound Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (14)

FDA medical device enforcement actions by Philips Ultrasound Inc

Date Product Reason Class
Sep 21, 2021 EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232 Ultrasound system software issue can cause an EchoNavigator error notificatio... Class II
Aug 19, 2021 Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100... Battery system data issue with the ultrasound system can intermittently cause... Class II
Aug 19, 2021 Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100... Battery system data issue with the ultrasound system can intermittently cause... Class II
Aug 6, 2021 EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2... Due to a software defect that can intermittently cause the system to lock-up ... Class II
Aug 6, 2021 Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5... Due to a software defect that can intermittently cause the system to lock-up ... Class II
Jul 22, 2021 EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7... Ultrasound system control panel arm swivel lock could fail, which could cause... Class II
Dec 24, 2020 Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5... Control panel arm assembly could have missing or loose screws where undue for... Class II
Dec 16, 2020 Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G... The manufacturer discovered an issue associated with the EPIQ Image Boost wit... Class II
Oct 27, 2020 All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, E... The manufacturer has determined that with certain uncommon workflows there is... Class II
Aug 30, 2019 Transducer S7-3t UDI (01)00884838067530 REF 989605439232 Used as accesso... The firm has discovered an issue associated with some Transesophageal (TEE) t... Class II
Aug 30, 2019 Transducer S8-3t UDI (01)00884838067523 REF 989605420183 Can be used w... The firm has discovered an issue associated with some Transesophageal (TEE) t... Class II
Aug 30, 2019 Transducer S7-3t UDI (01)00884838061439 REF 989605406772 Can be used w... The firm has discovered an issue associated with some Transesophageal (TEE) t... Class II
Aug 30, 2019 Transducer S8-3t UDI (01)00884838073524 REF 989605431171 Can be used a... The firm has discovered an issue associated with some Transesophageal (TEE) t... Class II
Apr 29, 2019 Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Model... There is a potential that the image of one patient could get unexpectedly mov... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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