Skip to content

Michigan Instruments Thumper Mechanical CPR Device recallZ-0119-2007 · Michigan Instruments, Inc. · initiated Aug 4, 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 first turned on, if improperly shut down-Operator Manual updated to include proper shut down procedures

FDA root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-0119-2007
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Aug 4, 2006
Posted by the FDA
Nov 3, 2006
Recalling firm
Michigan Instruments, Inc.
Quantity
1100
Product code
DRM
FDA submissions
K972525
Distribution
Worldwide- USA and countries of Brazil, Canada, China, Germany, Greece, Japan, Korea, Macau, Netherlands, Pakistan, Spain, Taiwan and United Kingdom.

Product description

Michigan Instruments Thumper Mechanical CPR Device; Model 1007.

Code information (models, lots, serial numbers)

All units with a manual configuration (as opposed to a pneumatic configuration).

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

How recalls are matched to devices · Editorial policy · Report an error on this page