The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled wate

FDA device recall Z-0933-2014 · posted 2014-02-05 · Terminated

Recall details

Recalling firm

Stryker Medical Division of Stryker Corporation

Reason for recall

Stryker Medical has identified that on some units of the MTA7900, there is a lack of a water temperature display while the unit is in Auto mode. While in Auto mode, only the patient temperature is displayed along with the set point. The water display will be blank during Auto mode. If the user wants to see the water temperature displayed and switches out of Auto mode to Manual mode, then back to

Action taken

On Dec. 27, 2013, Stryker Medical notified their consignees, identifying the product, reason for the recall and associated risks. Consignees were asked . Locate the units listed attach enclosed warning tags to the units listed. For units that do not have the water temperature displayed, advise staff not to switch to manual mode in order to display the water temperature. Stryker will make arrangements to update the software so that the water temperature will be displayed in both Auto and Manual modes. Fax (269-488-8691) or e-mail (ProductFieldAction@stryker.com ) the enclosed acknowledgment to confirm receipt of this notification. Please forward a copy of this letter to the new users and advise us of their new location and let Stryker know if any units have been discontinued. Questions or concerns, should be addressed to Stryker Customer Service at (1-800-327-0770). Monday-Friday 8 a.m-5 p.m. (ET).

Root cause

Device Design

Status

Terminated

Product code

DWJ

Quantity affected

1002 units

Distribution

nationwide and worldwide

Date initiated

2013-12-27

Date posted

2014-02-05

Date terminated

2014-11-04

Location

Portage, MI

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