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Terminated

Philips HeartStart XL, Model M4735A Defibrillator/Monitor

FDA Recall Z-0343-03 · Posted 2002-12-18

Recalling FirmPhilips Medical Systems, Inc. Cardiac & Monitoring Systems
Recall StatusTerminated
Product CodeMKJ
Date Initiated2002-11-25
Date Terminated2012-05-03
Product Quantity260 units

Reason for Recall

Defective energy switch may cause Defibrillator to turn off or charge to a different energy level than was selected.

Firm Action

On 11/25/02 Philips notified customers by letter and requested users to identify the device and use an alternate defibrillator. Philips systems representatives will repair the device in the field. Instructions, titled: 'Risk Mitigation Procedure,' were provided if the unit cannot be pulled from service.

Root Cause

Other

Distribution Pattern

AL, AZ, CA, CT, DE, FL, IL , IN, LA, NE, NY, PA, TX Nationwide Foreign: Canada, Algeria, Belgium, France, Great Britain, Ireland, Israel, Italy, Lebanon, Spain, Sweden, Hong Kong, Philippines, Singapore, Taiwan, China, Japan,Trinadad

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021453HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735APhilips Medical Systems · 2002-07-03K010634HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500BAgilent Technologies, Inc. · 2001-06-11K001725HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735AAgilent Technologies, Inc. · 2000-09-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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