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U.S. Department of Health and Human Services

Class 1 Device Recall JMC5A Ni Oxygen Concentrator

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 Class 1 Device Recall JMC5A Ni Oxygen Concentratorsee related information
Date Initiated by FirmDecember 09, 2024
Date PostedJanuary 03, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0795-2025
Recall Event ID 95818
510(K)NumberK230969 
Product Classification Generator, oxygen, portable - Product Code CAW
ProductJMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
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.
Recalling Firm/
Manufacturer		 JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD
No 36 Danyan Road, Lianxing Village
Danyang China
Manufacturer Reason
for Recall		Oxygen concentrator may melt or catch on fire during use.
FDA Determined
Cause 2		Component change control
ActionOn 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 recall@compasshealthbrands.com If you have any questions, please contact: 1-800-376-7263 x444, Monday-Friday 8:00 am EST - 5:00 pm EST, or email recall@compasshealthbrands.com On 12/18/2024, additional recall notices were sent adding additional affected devices.
Quantity in Commerce6,520
DistributionUS: OH
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = CAW
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