Recall Z-0795-2025 ยท CAW Generator, Oxygen, Portable
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD
JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
| Date | Jan 3, 2025 (initiated Dec 9, 2024) |
| Status | Open, Classified |
| Reason | Oxygen concentrator may melt or catch on fire during use. |
| Root cause | Component change control |
| 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 recall@c |
| Quantity | 6,520 |
| Distribution | US: OH |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K230969 | Oxygen Concentrator Jiangsu Jumao X-Care Medical Equipment Co., Ltd., Nov 9, 2023 |