FDA Medical Device Recalls (openFDA)
Michigan Instruments, Inc.: Michigan Instruments Thumper Mechanical CPR Device; Model 1007.
- Recall number
- Z-0119-2007
- Recalling firm
- Michigan Instruments, Inc.
- Product
- Michigan Instruments Thumper Mechanical CPR Device; Model 1007.
- Status
- Terminated
- Initiated
- 2006-08-04
- Posted
- 2006-11-03
- Terminated
- 2006-12-06
- 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.
- Lot, serial or model codes
- All units with a manual configuration (as opposed to a pneumatic configuration).
- 510(k) numbers
- ["K972525"]
- PMA numbers
- not on file
- Product code
- DRM
- Firm FEI
- 1821850
- Firm city
- Grand Rapids
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28