The Recall Desk

Manufacturer

Philips Medical Systems, Inc.

65 recalls in our database name Philips Medical Systems, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
65
Critical
0
Severe
14
Most recent
2016-04-06

Of the 65 recalls from Philips Medical Systems, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 14 (22%) 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.

51–65 of 65

  • HighFDA (Devices)·Z-1439-2014·2014-04-16

    Philips HeartStart XL+ Defibrillator Recalled for Therapy Board Malfunction

    Philips is recalling 19 HeartStart XL+ defibrillators because a therapy board component could malfunction, potentially affecting the device's ability to deliver therapy.

    Product
    Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automatic external defibrillator.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1155-2014·2014-03-19

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Shock Delivery Failure

    Philips is recalling HeartStart MRx Monitor/Defibrillators because they may display a Red X during automated tests, indicating a failure that could prevent the delivery of a shock or pacing.

    Product
    Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1194-2014·2014-03-19

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Q-CPR Meter Display Error

    Philips is recalling HeartStart MRx Monitor/Defibrillators with the Q-CPR Meter option because the device may incorrectly display a 'Do Not Touch the Patient' icon during defibrillation mode.

    Product
    Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08 The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the op
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1090-2014·2014-03-05

    Philips HeartStart MRx Monitor/Defibrillator Recalled for ESD Component Damage

    Philips is recalling HeartStart MRx Monitor/Defibrillators because a processor board component may be damaged by electrostatic discharge, disrupting ECG and SpO2 functionality.

    Product
    HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M3535A, M3536A, M3536J, M3536MC The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1109-2014·2014-03-05

    Philips HeartStart XL Defibrillators Recalled for Power Board Failure

    Philips is recalling 5,234 HeartStart XL Defibrillators/Monitors because a power board failure may prevent the device from defibrillating.

    Product
    Philips HeartStart XL, Defibrillator/Monitor Model number M4735A Product Usage: The M4735A HeartStart XL Defibrillator/Monitor is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1118-2014·2014-03-05

    Philips HeartStart MRx Monitor/Defibrillator Recalled for ECG Cable Wear

    Philips is recalling HeartStart MRx Monitor/Defibrillators because the ECG trunk cable and connector block may wear prematurely, causing an interrupted ECG signal.

    Product
    Philips HeartStart MRx Monitor/Defibrillator; Models: M3535A, M3536A, M3536J, M3536M, M3536M5, and M3536MC. Used for the termination of ventricular tachycardia and ventricular fibrillation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1120-2014·2014-03-05

    Philips HeartStart MRx Defibrillator Batteries Recalled for Shutdown Risk

    Philips is recalling 43,792 HeartStart MRx defibrillator batteries because they may shut down unexpectedly when exposed to high electromagnetic interference.

    Product
    HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1108-2014·2014-03-05

    Philips HeartStart MRx Defibrillators Recalled for Wireless Data Transmission Defect

    Philips is recalling 220 HeartStart MRx defibrillators because the Wireless Link upgrade may fail to transmit data in specific configurations.

    Product
    M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by tra
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-1110-2014·2014-03-05

    Philips HeartStart MRx Defibrillators Recalled for Wear Risk

    Philips is recalling HeartStart MRx monitor/defibrillators because therapy connections may wear prematurely, posing a risk to patients and caregivers.

    Product
    Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1107-2014·2014-03-05

    Philips HeartStart XL+ Defibrillator Recalled for Battery Charge Time Labeling Error

    Philips is recalling 7,157 HeartStart XL+ Defibrillators because the battery charge time at high temperatures is slightly longer than the 3 hours stated in the labeling.

    Product
    Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0613-2014·2014-01-08

    Philips HeartStart MRx Defibrillators Recalled for Potential Shutdown

    Philips is recalling HeartStart MRx monitor/defibrillators because they may shut down without warning if exposed to elevated electromagnetic interference.

    Product
    Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personn
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0584-2014·2014-01-08

    Philips Essenta DR X-ray System C-arm Casting Recall

    Philips is recalling 424 Essenta DR stationary X-ray systems because the C-arm casting may loosen and fall.

    Product
    Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta DR is a multifunctional stationary X-ray system, in which the swivel arm rotation, the vertical movement of the swivel arm and the SID adjustment are motorized. It is designed for radiograp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0593-2014·2014-01-08

    Philips HeartStart MRx Monitor/Defibrillator Recall for Labeling Error

    Philips is recalling 93 HeartStart MRx Monitor/Defibrillators because the first therapy energy setting is mislabeled as 10 instead of 1-10.

    Product
    Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A27, HeartStart MRx ALS Monitor (Grey) The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel tr
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0570-2014·2014-01-01

    Philips HeartStart MRx Defibrillator Recall for EtCO2 Display Error

    Philips is recalling HeartStart MRx defibrillators because they display a question mark instead of a value when patient CO2 levels fall below 7.6 mmHg.

    Product
    Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and q
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0431-2014·2013-12-11

    Philips Easy Diagnost Eleva Fluoroscopic Software Recall

    Philips Medical Systems is recalling 19 Easy Diagnost Eleva devices because they were delivered with outdated application software.

    Product
    Easy Diagnost Eleva Universal Fluoroscopic applications
    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.