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Terminated

biphasic LIFEPAK 500 automated external defibrillators (AEDs) with software version 4.4 or lower; Part Nos. 3011790-XXXXXX, D3100790-XXXXXX, and U3011790-XXXXXX . (XXXX indicates various non-contiguous numbers)

FDA Recall Z-1148-2007 · Posted 2007-08-04

Recalling FirmMedtronic Emergency Response Systems, Inc.
Recall StatusTerminated
Product CodeMKT
Date Initiated2007-06-13
Date Terminated2011-03-20
Product Quantity59,996 devices

Reason for Recall

Reduced Shock- the device may deliver 100 Joule (J) to a patient, which is less than the recommended factory minimum default setting of 200 J.

Firm Action

On June 13, 2007 the recalling firm sent a letter dated June 11, 2007, titled URGENT - MEDICAL DEVICE CORRECTIVE ACTION. The letter advises of the situation, recommends to the consignee to set defibrillator to FIXED Sequence Protocol and to contact the firm for a FLEXIBLE Sequence Energy Protocol. The letter provides an instruction sheet and a response sheet to be faxed back to the company.

Root Cause

Other

Distribution Pattern

Worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K955854LIFEPAK 500Physio-Control Corp. · 1996-11-04

Official Source

View FDA Recall →

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

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