Device product

JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L

Z-0795-2025

December 09, 2024

Class I

Product summary

Firm: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD
Event: Event 95818
Status: Ongoing
Classification: Class I
Quantity: 6,520
Official record key: device-enforcement:Z-0795-2025

Official wording

Reason: Oxygen concentrator may melt or catch on fire during use.

Code information: UDI-DI: 00092237623152. Serial Number Ranges: JA2311000001-JA2311000740, JA2311000741-JA2311001480, JA2311001481-JA2311002220, JA2311002221-JA2311002960, JA2311002961-JA2311003700, JA2312000001-JA2312000740, JA2312000741-JA2312001480, JA2312001481-JA2312002080, JA2401000001-JA2401000740.

Distribution pattern: US: OH

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Oxygen concentrator may melt or catch on fire during use.