FDA Device recall Z-1537-2013
Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628251) 1053614 (98980…
- FDA Device
- Class I
- terminated
- Published 2013-06-26
On 2013-06-26 the FDA classified a Class I recall of Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628251) 1053614 (98980… by Respironics California, citing respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue with the software on the V60 Power Management Board Assembly. If a component fails on….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1537-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-06-04 |
| Published | 2013-06-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Respironics California |
| Distribution | US |
Product
Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628251) 1053614 (989805612101) 1053615 (989805613391) 1053616 (989805613661) 1053617 (989805611761) 1053618 (n/a) R1053618 (n/a) 1076709 (n/a) 1076715 (989805627411) 1076716 (989805627431) 1076717 (989805627441) DU1053617 (989805616411) U1053614 (989805636441) U1053617 (989805636631) Power Mgmt. Board, Respironics Material P/N: 1054358, Philips 12 Digit P/N: 4536561512581. The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The V60 Ventilator is intended to support pediatric patients weighing 20kg (44 lbs.) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. It is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.
Reason
Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue with the software on the V60 Power Management Board Assembly. If a component fails on the Power Management Board Assembly, it may cause ventilator support to be lost with potentially no audible alarm from the ventilator.
Identifiers
| code_info | V60 Unit Serial Numbers: 201001587 201001594 100066488 100017106 100017114 100017223 100017224 100017230 10001…V60 Unit Serial Numbers: 201001587 201001594 100066488 100017106 100017114 100017223 100017224 100017230 100017234 100006282 100078254 100078560 100078563 100080057 100013022 100004544 100013661 100013664 100013472 100013658 100042656 100049569 100005498 100014349 100014422 100014430 100014432 100014436 100014438 100014439 100014640 100014643 100014644 100014935 100014936 100014938 100014939 100015003 100082002 100082006 100082083 100082084 100045123 100045295 100030471 100030479 100030484 100030602 100034394 100034398 100034584 100034587 100041191 100014350 100025026 100025032 100025927 100025929 100025930 100025943 100025993 100025994 100025999 201001894 100057883 100057980 100035420 100035575 100035733 201002953 100082192 100082207 100082208 100042116 100021037 100021042 201001495 201001501 100072453 100073915 100037767 100037873 100038506 100038513 100038519 100038807 100038809 100038812 100038 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1537-2013%22
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