Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive homecare devices, for e
FDA device recall Z-0746-2016 · posted 2016-02-03 · Terminated
Recall details
- Recalling firm
- Resmed Corporation
- Reason for recall
- Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue.
- Action taken
- ResMed sent an Urgent Safety Alert dated January 13, 2016, to all affected customers. The Alert identified the product, the problem, and the action to be taken by the customer. The notification letter provided the following instructions to distributors Field devices can be upgraded using ResMed Service Software or at an authorized ResMed Service Center. Contact Astral Support for further details. The SR2 software update will be available free of charge and should be implemented for all devices within the two-year service cycle or before at the customers preference. To acknowledge receipt of this Astral Safety Alert, submit this form. For any questions call Astral Support: 855-245-4640
- Root cause
- Software design
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 14,736
- Distribution
- Worldwide Distribution - US including VA, FL, MO, CA, LA, TX, NJ, NH, NC, WV, MI, ID, OK, MI, MN, UT, CT, IL, AZ, UT, KY, MT, PA, RI, TN, DE, NE, LA, NY, SC, WY, IN, VA, GA, CO and Internationally to
- Date initiated
- 2016-01-13
- Date posted
- 2016-02-03
- Date terminated
- 2016-04-22
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ASTRAL VENTILATOR (K133868) | Resmed, Ltd. | 2014-06-04 |