Device Recall LIFEPAK 의 리콜

Recall

31111

Class 1

Z-0562-05

2005-02-03

2005-03-10

Terminated

United States

2006-08-21

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37172

Potential to not detect patients at the low end of the patient impedance range.

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.