JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
Recall
- Recall Number
- Z-0795-2025
- Event Number
- 95818
- Firm
- JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD No
- FEI Number
- 3014810929
- Product Code
- CAW
- Status
- Open, Classified
- Root Cause
- Component change control
- Initiated
- December 9, 2024
- Posted
- January 3, 2025
- Address
- 36 Danyan Road, Lianxing Village Danyang China
Description
JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
Oxygen concentrator may melt or catch on fire during use.
On 11/26/2024, a recall notice was sent a distributor asking them to take the steps below. On 12/09/2024, recall notices were sent from the distributor to customers who were asked to do the following: This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. All units from the specified serial number range MUST be immediately discontinued from use and removed from service and promptly returned. Complete and return the acknowledgement and receipt form via email to [email protected] If you have any questions, please contact: 1-800-376-7263 x444, Monday-Friday 8:00 am EST - 5:00 pm EST, or email [email protected] On 12/19/2024, additional recall notices were sent adding additional affected devices.
US: OH
6,520