Michigan Instruments Thumper Mechanical CPR Device; Model 1007.
FDA device recall Z-0119-2007 · posted 2006-11-03 · Terminated
Recall details
- Recalling firm
- Michigan Instruments, Inc.
- Reason for recall
- Failure to initiate compressions when first turned on, if improperly shut down-Operator Manual updated to include proper shut down procedures
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DRM
- Quantity affected
- 1100
- Distribution
- Worldwide- USA and countries of Brazil, Canada, China, Germany, Greece, Japan, Korea, Macau, Netherlands, Pakistan, Spain, Taiwan and United Kingdom.
- Date initiated
- 2006-08-04
- Date posted
- 2006-11-03
- Date terminated
- 2006-12-06
- Location
- Grand Rapids, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THUMPER (K972525) | Michigan Instruments, Inc. | 1997-10-02 |