Portable Oxygen Concentrator with Erroneous Calibration Values
Ohio Medical Corporation is recalling 36 units of the GCE HEALTHCARE Zen-O lite portable oxygen concentrator due to erroneous calibration values that may cause the device's alarm for low oxygen purity to function incorrectly as the device ages.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a risk-of-harm defect (loss of alarm function for critical device safety indicator). The source explicitly addresses a device designed to deliver medical oxygen where the safety alarm may fail to alert users of inadequate oxygen purity, posing significant risk to vulnerable patients who depend on the device. No illnesses or injuries are reported in the source.
Plain-English summary
Ohio Medical Corporation is recalling the GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S due to erroneous calibration values. A total of 36 units with specific serial numbers have been identified and distributed nationwide to AR, FL, VA, ND, MS, MN, CA, NV, and KY.
As the device ages, oxygen purity will gradually decrease. Due to the calibration error, the device's alarm that indicates low oxygen purity will function incorrectly and may not alert users when oxygen purity becomes low. This could expose patients to inadequate oxygen delivery without proper warning.
Patients who have received one of the affected units should contact their durable medical equipment provider or Ohio Medical Corporation for instructions on device replacement or repair. The serial numbers of the affected units are listed in the FDA recall notice.
The recalled product
- Product
- GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
- Manufacturer
- Ohio Medical Corporation
- Affected units
- 36
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial Numbers: ZL316367
- ZL316446
- ZL316462
- ZL316475
- ZL316481
- ZL316484
- ZL316490
- ZL316493
- ZL316503
- ZL317057
- ZL317087
- ZL317088
- ZL317090
- ZL322386
- ZL322387
- ZL322390
- ZL322392
- ZL322409
- ZL322412
- ZL322439
Distribution
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