Michigan Instruments Thumper Mechanical CPR Device; Model 1007.
FDA Recall Z-0119-2007 · Posted 2006-11-03
Recalling FirmMichigan Instruments, Inc.
Recall StatusTerminated
Product CodeDRM
Date Initiated2006-08-04
Date Terminated2006-12-06
Product Quantity1100
Reason for Recall
Failure to initiate compressions when first turned on, if improperly shut down-Operator Manual updated to include proper shut down procedures
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide- USA and countries of Brazil, Canada, China, Germany, Greece, Japan, Korea, Macau, Netherlands, Pakistan, Spain, Taiwan and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.