The Recall Desk

Manufacturer

Philips Medical Systems North America Inc.

5 recalls in our database name Philips Medical Systems North America Inc. as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2014-03-26

Of the 5 recalls from Philips Medical Systems North America Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–5 of 5

  • HighFDA (Devices)·Z-1232-2014·2014-03-26

    Philips Recalls HeartStart Home and OnSite AEDs Due to Solder Residue

    Philips is recalling HeartStart Home and OnSite AEDs because solder residue may prevent the device from delivering therapy in an emergency.

    Product
    Philips 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1263-2014·2014-03-26

    Philips EPIQ 5 Ultrasound System Recalled for Incorrect Doppler Velocity Readings

    Philips is recalling EPIQ 5 Ultrasound Systems because they may report incorrect Doppler velocities when using specific settings, potentially affecting diagnostic accuracy.

    Product
    Philips 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 D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1225-2014·2014-03-26

    Philips HeartStart FR3 AED Recalled for Potential Circuit Board Separation

    Philips is recalling HeartStart FR3 AEDs because the circuit board may separate, preventing the device from delivering a shock during an emergency.

    Product
    Philips 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)
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-1264-2014·2014-03-26

    Philips EPIQ 7 Ultrasound System Recalled for Incorrect Doppler Velocity Readings

    Philips is recalling EPIQ 7 Ultrasound Systems because they may report incorrect Doppler velocities when using specific settings, potentially affecting diagnostic accuracy.

    Product
    Philips Model EPIQ 7 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 D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0368-2014·2013-11-27

    Philips EPIQ 7 Ultrasound System Recalled for Date Format Calculation Errors

    Philips is recalling EPIQ 7 Ultrasound Systems because using the International System Date Format may cause calculation errors in Gestational Age and Established Due Date.

    Product
    EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Philips Medical Systems

company based in Hamburg, Germany

Country
Germany
Founded
1987
Parent company
Philips (Germany)

Official website

Source: Wikidata (Q2087959), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.

Philips Medical Systems North America Inc. recalls · The Recall Desk