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Terminated

Medi-Therm Hyper/Hypothermia System, MTA7900

FDA Recall Z-2058-2017 · Posted None

Recall StatusTerminated
Product CodeDWJ
Date Initiated2017-03-29
Date Terminated2017-09-18
Product Quantity119

Reason for Recall

The water may reheat too quickly if the unit is in "Automatic" mode, switched to "Manual" mode to view water temperature, and then switched back to "Automatic" mode.

Firm Action

Stryker sent an URGENT: MEDICAL DEVICE CORRECTION notification dated March 29, 2017, were sent to the affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Actions needed 1. Locate the units listed on the attached business reply form and identify the address where they can be serviced. 2. In the interim, until the service can be performed, there are additional actions that users can and should take to ensure that the product operates safely. a. Attach the enclosed warning tags to the units listed in this notice. b. 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. 3. Return the enclosed business reply form to confirm receipt of this notification by fax 269 488 8691 or email [email protected]. 4. Upon receipt of the completed business reply form, Stryker will contact you to arrange for the modification/repair of your Medi-Therm unit. 5. If you have loaned or sold any of the products listed in this letter, please forward a copy of this notice to the new users and advise us of their new location in the space provided on the business reply form. 6. If you have disposed of any of these units and they are no longer in use, please, advise us of their obsolescence by providing us with their serial number in the space provided on the business reply form. For further questions, please call (800) 327-0770.

Root Cause

Software design

Distribution Pattern

USA (nationwide) Distribution and Internationally to Colombia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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