JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
FDA Recall Z-0795-2025 · Posted 2025-01-03
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Recalling FirmJIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD
Recall StatusOpen, Classified
Product CodeCAW
Date Initiated2024-12-09
Product Quantity6,520
Reason for Recall
Oxygen concentrator may melt or catch on fire during use.
Firm Action
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.
Root Cause
Component change control
Distribution Pattern
US: OH
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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