Recall Z-0119-2007 ยท DRM Compressor, Cardiac, External
Michigan Instruments, Inc.
Michigan Instruments Thumper Mechanical CPR Device; Model 1007.
| Date | Nov 3, 2006 (initiated Aug 4, 2006) |
| Status | Terminated |
| Reason | Failure to initiate compressions when first turned on, if improperly shut down-Operator Manual updated to include proper shut down procedures |
| 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 | 1100 |
| Distribution | Worldwide- USA and countries of Brazil, Canada, China, Germany, Greece, Japan, Korea, Macau, Netherlands, Pakistan, Spain, Taiwan and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972525 | THUMPER Michigan Instruments, Inc., Oct 2, 1997 |