Recall Register

Food, drugs, devices › Firms

Philips Medical Systems North America Inc.

FDA recalling firm · 4 enforcement events · 5 product records · 2013–2014 · WA

Philips Medical Systems North America Inc. has 4 FDA enforcement events on this register (5 product records) between 2013 and 2014: 4 device; the busiest year was 2014 with 3.

0% of its events are Class I; the most common class is Class II (4). 0 events are listed as ongoing; the recalling firm's address is in WA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
28 Feb 2014Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206 EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of Doppler velocity results values are used to…DeviceClass II2Terminated
6 Feb 2014Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt, apply the pads. A training class in CPR/AED use is…DeviceClass II1Terminated
6 Feb 2014Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389. The HeartStart FR3 is a battery powered automated external defibrillator (AED) designed for use by responders who have been trained in Basic Life Support (BLS), Advanced Life Support (ALS), or another physician-authorized…DeviceClass II1Terminated
17 Oct 2013EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis.DeviceClass II1Terminated

By type and class

Device4
Class II4

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

13
15
17
19
21
23
25
Enforcement events for Philips Medical Systems North America Inc. by year initiated.

Questions and answers

How many FDA recalls has Philips Medical Systems North America Inc. had?

4 enforcement events (5 product records) on this register, 2013–2014: 4 device.

Are any Philips Medical Systems North America Inc. recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Philips Medical Systems North America Inc. recalls?

4 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.