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DeVilbiss Healthcare LLC Recall 91112

Description: DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q

DeVilbiss Healthcare LLC Recall 91112 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0724-2023
Event ID91112
Event DescriptionDeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
Product TypeDevices
DistributionUS Nationwide. Foreign distribution pending.
Quantity1004315 (US); 414559 (OUS)
Recall ReasonThe 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.
Device Classification20221228
Device Code InfoModel 525DS UDI-DI 00885304000846 All Lots Model 525DS-Q UDI-DI 00885304009689 All Lots
Center Classification Date20221219
Recall Initiation Date20221118
Recalling FirmDeVilbiss Healthcare LLC
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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