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Draeger GT500. GlobeTrotter Transport System. Catalog… recallZ-1052-2008 · Draeger Medical, Inc. · initiated Jan 31, 2008

Terminated All recalls posted in March 2008

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 Draeger Medical, 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

Heating failure- The power board which controls the incubator heater may not regulate the temperature properly resulting in a high temperature alarm and a loss of temperature control within the patient compartment.

FDA root cause category: Nonconforming Material/Component

What the company is doing

The firm notified consignees on 2/1/08, by an Important Safety Notice. The letter instructed users to remove any units from use until a Draeger Service Representative can replace the power board. A Service Representative will be in contact to schedule a service visit. For questions concerning this recall please contact 215-660-2418 or [email protected].

Recall details

Recall number
Z-1052-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jan 31, 2008
Posted by the FDA
Mar 18, 2008
Recalling firm
Draeger Medical, Inc.
Quantity
2 units
Product code
FMZ
FDA submissions
K001019
Distribution
Worldwide Distribution-- USA including states MO, OH, and PR, and countries of Australia, Canada, Columbia, Israel, UAE, France, China, Italy, Denmark, Switzerland, and UK.

Product description

Draeger GT500. GlobeTrotter Transport System. Catalog Number: MU20508, Draeger Medical, Inc., Telford, PA 18969

Code information (models, lots, serial numbers)

Serial Numbers: PK00983 and PK00982

Other devices under the same FDA submission

1 device cleared under K001019 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 46742).

Sources and updates

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