JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
FDA device recall Z-0795-2025 · posted 2025-01-03 · Open, Classified
Recall details
- Recalling firm
- JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD
- Reason for recall
- Oxygen concentrator may melt or catch on fire during use.
- Action taken
- 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@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 12/19/2024, additional recall notices were sent adding additional affected devices.
- Root cause
- Component change control
- Status
- Open, Classified
- Product code
- CAW
- Quantity affected
- 6,520
- Distribution
- US: OH
- Date initiated
- 2024-12-09
- Date posted
- 2025-01-03
- Location
- Lianxing Village Danyang, China
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Oxygen Concentrator (K230969) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 2023-11-09 |