The firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings that applied parts in contact with the patient may in some situations exceed 41 degrees Celsius (105.8 degrees Fahrenheit), clarification on expected service life, and the need for maintenance to certain components.
Reason for recall: The firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings that applied parts in contact with the patient may in some situations exceed 41 degrees Celsius (105.8 degrees Fahrenheit), clarification on expected service life, and the need for maintenance to certain components. Distribution: US Nationwide. Foreign distribution pending. Quantity: 1004315 (US); 414559 (OUS) Lot/code info: Model 525DS UDI-DI 00885304000846 All Lots Model 525DS-Q UDI-DI 00885304009689 All Lots
00885304000846, 00885304009689
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.