Class 3 Device Recall Thumper mechanical cardiopulmonary resuscitator

• Date Initiated by Firm: August 04, 2006
• Date Posted: November 03, 2006
• Recall Status: Terminated on December 06, 2006
• Recall Number: Z-0119-2007
• Recall Event ID: 35934
• 510(K)Number: K972525
• Product Classification: mechanical cardiopulmonary resuscitator - Product Code DRM
• Product: Michigan Instruments Thumper Mechanical CPR Device; Model 1007.
• Code Information: All units with a manual configuration (as opposed to a pneumatic configuration).
• Recalling Firm/ Manufacturer: Michigan Instruments, Inc.; 4717 Talon Court S.E.; Grand Rapids MI 49512-5408
• For Additional Information Contact: 800-530-9939 Ext. 312
• Manufacturer Reason for Recall: Failure to initiate compressions when first turned on, if improperly shut down-Operator Manual updated to include proper shut down procedures
• FDA Determined 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 in Commerce: 1100
• Distribution: Worldwide- USA and countries of Brazil, Canada, China, Germany, Greece, Japan, Korea, Macau, Netherlands, Pakistan, Spain, Taiwan and United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DRM