Recall Z-0178-2007
Michigan Instruments, Inc. · initiated September 14, 2006
Product
Michigan Instruments Thumper Mechanical CPR Device; Model 1007, Part number 15000.
Codes / lots: All units sold in Japan (All serial numbers with 7- or 9- followed by 4 numbers; e.g. 7-xxxx or 9-xxxx).
Reason for recall
Failure to initiate compressions when turned on.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-0178-2007
- Initiated
- September 14, 2006
- Posted by FDA
- November 14, 2006
- Terminated
- December 6, 2006
- Product code
- DRM – Compressor, Cardiac, External
- Quantity
- 639
- Distribution
- Japan.
- Recalling firm
- Michigan Instruments, Inc., Grand Rapids, MI