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).
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