Class 3 Device Recall Thumper

• Date Initiated by Firm: September 14, 2006
• Date Posted: November 14, 2006
• Recall Status: Terminated on December 06, 2006
• Recall Number: Z-0178-2007
• Recall Event ID: 36313
• 510(K)Number: K972525
• Product Classification: Compression device - Product Code DRM
• Product: Michigan Instruments Thumper Mechanical CPR Device; Model 1007, Part number 15000.
• Code Information: All units sold in Japan (All serial numbers with 7- or 9- followed by 4 numbers; e.g. 7-xxxx or 9-xxxx).
• Recalling Firm/ Manufacturer: Michigan Instruments, Inc.; 4717 Talon Court S.E.; Grand Rapids MI 49512-5408
• For Additional Information Contact: Ryoji Fujisawa; 81-48-988-4411
• Manufacturer Reason for Recall: Failure to initiate compressions when turned on.
• FDA Determined Cause: Other
• Action: 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.
• Quantity in Commerce: 639
• Distribution: Japan.
• 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