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Terminated

Michigan Instruments Thumper Mechanical CPR Device; Model 1007, Part number 15000.

FDA Recall Z-0178-2007 · Posted 2006-11-14

Recalling FirmMichigan Instruments, Inc.
Recall StatusTerminated
Product CodeDRM
Date Initiated2006-09-14
Date Terminated2006-12-06
Product Quantity639

Reason for Recall

Failure to initiate compressions when turned on.

Firm 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.

Root Cause

Other

Distribution Pattern

Japan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K972525THUMPERMichigan Instruments, Inc. · 1997-10-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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