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).
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