Michigan Instruments Thumper Mechanical CPR Device; Model 1007, Part number 15000.
FDA device recall Z-0178-2007 · posted 2006-11-14 · Terminated
Recall details
- Recalling firm
- Michigan Instruments, Inc.
- Reason for recall
- Failure to initiate compressions when turned on.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DRM
- Quantity affected
- 639
- Distribution
- Japan.
- Date initiated
- 2006-09-14
- Date posted
- 2006-11-14
- Date terminated
- 2006-12-06
- Location
- Grand Rapids, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THUMPER (K972525) | Michigan Instruments, Inc. | 1997-10-02 |