Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0933-2014 — The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to accessory Gaymar Hyper/Hypothermia blanket(s)/body wrap(s). The blanket/body wrap provides an interface for heating or cooling the patient. Accessory

U.S. FDA — Device Enforcement · United States · 2013-12-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0933-2014
Date of alert: 2013-12-27
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Stryker Medical Division of Stryker Corporation
Product category: device
Product type: Devices

Reported risk: 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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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