—#36309

Product

Philips Heartstart MRx Monitor/Defibrillator Models: M3535A (Hospital Use) , M3536A (EMS Use)

FDA product code: MKJ — Automated External Defibrillators (Non-Wearable)
Device class: Class 3
Medical specialty: Cardiovascular
510(k) numbers: K031187
Affected lot / code info: Software versions A.02.00 and lower

Why it was recalled

In Software versions below A.02.00, with the sync function enabled and the device switched from manual to AED, there may be an unexpected delay in delivery of energy

Root cause (FDA determination)

Other

Action the firm took

Philips notified customers on 12/13/04 by letter. Users are provided with action required to Mitigate Risk' until the correction is made by a Systems representative.

Recalling firm

Firm: Philips Medical Systems
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: Nationwide Foreign:Canada, Austria, Australlia, Belgium, China, Denmark, Finland, France, Germany, Israel, Italy,Kuwait, Latvia, Lebannon, Libya, Netherland,Norway, Portugal, Qatar, Russia, Singapore,South Africa, Spain, Switzerland, Sweden, Taiwan, Thailand,Tunisia, UK, United Arab Emirates, Yemen

Timeline

Recall initiated: 2004-12-15
Posted by FDA: 2004-12-21
Terminated: 2016-02-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #36309. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.