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Terminated

HeartStart XL Defibrillator/Monitor, Model: M4735A

FDA Recall Z-0062-2008 · Posted 2007-10-25

Recalling FirmPhilips Medical Systems
Recall StatusTerminated
Product CodeMKJ
Date Initiated2007-09-04
Date Terminated2016-08-09
Product Quantity147 boards

Reason for Recall

Inadequate shipping package causing damage to control boards resulting in unit failure. Failure to deliver therapy (defibrillation, pacing or cardioversion) may occur as a result of undetected damage to the PCB assembly.

Firm Action

Philips Medical notified accounts (Distributors/Healthcare Customers) by letter dated 9/4/07. Users are requested if possible to remove the unit from service. Firm will have Field representative conduct correction.

Root Cause

Package design/selection

Distribution Pattern

Puerto Rico, Canada, Argentina, Australia, Brazil, China, Domincan Republic, Czech Republic, Hong Kong, India, Japan, Korea, Macau, Singapore, Spain, South Africa, Slovenia, Sweden, Switzerland, Ireland, UK, France, Kuwait, Poland, and Germany

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021453HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735APhilips Medical Systems · 2002-07-03

Official Source

View FDA Recall →

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

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