Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0178-2007

Michigan Instruments Thumper Mechanical CPR Device; Model 1007, Part number 15000

Michigan Instruments / initiated 2006-09-14 / Terminated

Michigan Instruments, Inc. began a recall of Michigan Instruments Thumper Mechanical CPR Device; Model 1007, Part number 15000 on . The reason FDA records is "Failure to initiate compressions when turned on". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0178-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Michigan Instruments
Product
Michigan Instruments Thumper Mechanical CPR Device; Model 1007, Part number 15000.
Product code
DRM Compressor, Cardiac, External
Reason for recall
Failure to initiate compressions when turned on.
FDA root cause
Other
Action
The Japanese distributor is instructed by letter dated 9/14/06 to drill a small hole in the male checked connector at the base of the column in order to allow rapid bleed off of the pressure and to give customers a revised operators manual.
Quantity in commerce
639
Distribution
Japan.
Product codes and lots
All units sold in Japan (All serial numbers with 7- or 9- followed by 4 numbers; e.g. 7-xxxx or 9-xxxx).