FDA Device recall Z-0746-2016
Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive homecare devices, for example, the largest…
- FDA Device
- Class II
- terminated
- Published 2016-02-10
On 2016-02-10 the FDA classified a Class II recall of Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive homecare devices, for example, the largest… by Resmed, citing resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0746-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-13 |
| Published | 2016-02-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Resmed |
| Distribution | AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KY, LA, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OK, PA, RI, SC, TN, TX, UT, VA, WV, WY |
Product
Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive homecare devices, for example, the largest population of patients on the Astral device is COPD patients primarily using the device at night with some daytime use for recovery breathing. While it is possible that there may be scenarios where critically dependent patients may encounter this scenario, the likelihood of this leading to harm is negligible because critically dependent patients will have a form of backup ventilation as standard of care.
Reason
Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue.
Identifiers
| code_info | Serial Numbers: 22141311907 22151237236 22141311910 22151237228 22151572231 22151666684 22151237233 22151135073…Serial Numbers: 22141311907 22151237236 22141311910 22151237228 22151572231 22151666684 22151237233 22151135073 22141458006 22151572230 22151135061 22151397090 22151008941 22141311872 22151614456 22151135058 22141269867 22151555593 22151483516 22151483534 22151325490 22151163315 22141308812 22151555584 22151311349 22141311870 22151602423 22151325513 22151555618 22151165427 22151165476 22151468419 22151397046 22151073624 22151165376 22151602615 22151445731 22151326787 22151483592 22151602601 22151165492 22151555637 22151311317 22151608382 22151608488 22151310708 22151326727 22151165536 22151468487 22151165539 22151503647 22151310704 22151602504 22141311844 22151572224 22151503641 22151399554 22141668174 22151468486 22151397041 22151602409 22151311327 22151483580 22151483551 22151602621 22151614517 22151602637 22151445633 22151602631 22151009061 22151397094 22151397076 22151445751 22151483560 22151555656 22151483 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0746-2016%22
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