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NCAR Recall
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Reference Number:
mdprc 017 07 12 000
Date submitted:
7/8/2012
Manufacturer:
Pace Medical, Inc
Device Type:
TEMPORARY EXTERNAL PACING, MICRO-PACE 4580
Description:
TEMPORARY EXTERNAL PACING (WITHOUT DEFIBRILLATION)
Medical Device Identifier:
Software version: 2.1 or 2.2
Reason of Field Safety Corrective Action:
Pace Medical has reviewed two reports of a sensing anomaly.
Remedy Action:
New component will prevent similar events from occurring which may affect sensing of the device. A simple change of a resistor value is required.
Athorized Representative/Importer/Distributor:
N/A
Report Source:
NCAR
Source Ref. Number:
UK-2012-07-03-124
SFDA Comments:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:
Pace Medical.pdf
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