Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0119-2007

Michigan Instruments Thumper Mechanical CPR Device; Model 1007

Michigan Instruments / initiated 2006-08-04 / Terminated

Michigan Instruments, Inc. began a recall of Michigan Instruments Thumper Mechanical CPR Device; Model 1007 on . The reason FDA records is "Failure to initiate compressions when first turned on, if improperly shut down-Operator Manual updated to include proper shut down procedures". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0119-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Michigan Instruments
Product
Michigan Instruments Thumper Mechanical CPR Device; Model 1007.
Product code
DRM Compressor, Cardiac, External
Reason for recall
Failure to initiate compressions when first turned on, if improperly shut down-Operator Manual updated to include proper shut down procedures
FDA root cause
Other
Action
Consignees were sent a letter dated 8/4/06 with additional instructions for use. A second letter was sent on 9/1/06 to correct the new instructions provided in the first letter for page 19 of the instructions.
Quantity in commerce
1100
Distribution
Worldwide- USA and countries of Brazil, Canada, China, Germany, Greece, Japan, Korea, Macau, Netherlands, Pakistan, Spain, Taiwan and United Kingdom.
Product codes and lots
All units with a manual configuration (as opposed to a pneumatic configuration).