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Michigan Instruments Thumper Mechanical CPR Device recallZ-0178-2007 · Michigan Instruments, Inc. · initiated Sep 14, 2006

Terminated All recalls posted in November 2006

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Michigan Instruments, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Failure to initiate compressions when turned on.

FDA root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-0178-2007
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Sep 14, 2006
Posted by the FDA
Nov 14, 2006
Recalling firm
Michigan Instruments, Inc.
Quantity
639
Product code
DRM
FDA submissions
K972525
Distribution
Japan.

Product description

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

Code information (models, lots, serial numbers)

All units sold in Japan (All serial numbers with 7- or 9- followed by 4 numbers; e.g. 7-xxxx or 9-xxxx).

Other devices under the same FDA submission

1 device cleared under K972525 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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