LIFEPAK 500 AED.
This recall has been terminated (originally issued March 10, 2005).
- Recall Initiated
- February 3, 2005
- Posted
- March 10, 2005
- Terminated
- August 21, 2006
- Recall Number
- Z-0562-05
- Quantity
- 2,349
- Firm Location
- Redmond, WA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential to not detect patients at the low end of the patient impedance range.
Distribution
Devices were distributed to 750 domestic consignees dn 16 international consignees.
Lot / Code Info
Serial numbers - various, noncontiguous Part numbers - 3005400-XXX, D3005400-XXX, U3005400-XXX
Root Cause
Device Design
Action Taken
On 2/3/05 the firm issued a 'Medical Device Correction' letter dated January 2005 to their customers. The letter advised customers of the issue and stated a representative from the firm would visit each facility to update affected unit. On 2/25/05 a nationwide press release was issued. On 3/1/05 the firm began telephoning each customer, this was followed by another letter titled MEDICAL DEVICE RECALL. The letter advises of the issue and recommends defibrillators remain in service when no alternative is available until the unit can be corrected. Each unit will be replaced or corrected. On 4/22/05 the firm issued another letter, via certified mail return receipt, expanding their recall. Letter was issued to all customers affected by the expansion of the recall. On 4/22/05 the firm issued a press release advising of the expansion of the recall. The firm's web site also provides a listing of affected units.