Philips Medical Systems, Inc. Recalls

Recall history in this database

Classification mix: Class II: 11.

Medical DeviceApr 6, 2016

Philips Medical Systems Foot Switches used with Philips MultiDiagnost Eleva with Flat recall — FDA Z-1279-2016

Loss of key image functionality due to a bent pedal of the Footswitch.

Class IIFDA: TerminatedPhilips Medical Systems, Inc.

Medical DeviceApr 6, 2016

Philips Medical Systems Foot Switches used with the following systems: Philips Allura Xper recall — FDA Z-1280-2016

Loss of key image functionality due to a bent pedal of the Footswitch.

Class IIFDA: TerminatedPhilips Medical Systems, Inc.

Medical DeviceDec 16, 2015

Philips IntelliVue Information Center iX recall — FDA Z-0374-2016

Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification

Class IIFDA: TerminatedPhilips Medical Systems, Inc.

Medical DeviceDec 9, 2015

Philips Healthcare INTEGRIS vascular System Model : 722122 Product Usage: The Allura Xper recall — FDA Z-0349-2016

Monitor Ceiling Suspension system may fall

Class IIFDA: TerminatedPhilips Medical Systems, Inc.

Medical DeviceDec 9, 2015

Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product Usage: The Allura Xper recall — FDA Z-0354-2016

Monitor Ceiling Suspension system may fall

Class IIFDA: TerminatedPhilips Medical Systems, Inc.

Medical DeviceDec 9, 2015

Philips Healthcare INTEGRIS H5000F/Allura 9F Model : 722017 Product Usage: The Allura Xper recall — FDA Z-0350-2016

Monitor Ceiling Suspension system may fall

Class IIFDA: TerminatedPhilips Medical Systems, Inc.

Medical DeviceDec 9, 2015

Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10 Allura Xper FD20 recall — FDA Z-0346-2016

Monitor Ceiling Suspension system may fall

Class IIFDA: TerminatedPhilips Medical Systems, Inc.

Medical DeviceDec 9, 2015

Philips Healthcare INTEGRIS cardio system Model : 722121 Product Usage: The Allura Xper recall — FDA Z-0348-2016

Monitor Ceiling Suspension system may fall

Class IIFDA: TerminatedPhilips Medical Systems, Inc.

Medical DeviceDec 9, 2015

Philips Medical Systems Patient Support Material Number: 9890 010 87431 used with recall — FDA Z-0364-2016

The hook does not securely hold the footplate in vertical position. Therefore the footplate can fall or swing down and may hurt the operator or patient.

Class IIFDA: TerminatedPhilips Medical Systems, Inc.

Medical DeviceDec 9, 2015

Philips Medical Systems Patient Support Material Number: 9890 010 87431, used recall — FDA Z-0365-2016

The hook does not securely hold the footplate in vertical position. Therefore the footplate can fall or swing down and may hurt the operator or patient.

Class IIFDA: TerminatedPhilips Medical Systems, Inc.

Medical DeviceDec 9, 2015

Philips Healthcare Xper vascular system Model : 722124 Product Usage: The Allura Xper series recall — FDA Z-0352-2016

Monitor Ceiling Suspension system may fall

Class IIFDA: TerminatedPhilips Medical Systems, Inc.

Understanding this recall history

This page summarizes recall records in which the official source identifies Philips Medical Systems, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.

Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.