Respironics V60 Ventilator — Class I medical device recall Z-1537-2013
Terminated recall by Respironics California Inc, reported 2013-06-26, distributed nationwide. Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue with the softwar
| Recall number | Z-1537-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Respironics California Inc, Carlsbad, CA, United States |
| Recall initiated | 2013-06-04 |
| Classified | 2013-06-17 |
| Reported by FDA | 2013-06-26 |
| Terminated | 2014-04-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BH, BO, BR, CA, CH, CL, CN, CZ, DE, DK, EC, EG, ES, FI, FR, GB, HK, HR, ID, IE, IL, IN, IR, IS, IT, KE, KR, KW, LB, MA, MT, MX, MY, NL, NO, NZ, OM, PA, PE, PH, PL, PT, PY, QA, SA, SE, SG, SI, TH, TR, TW, VN, ZA |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00989805616411, 00989805627431, 00989805636631 |
| Serial numbers | 100, 100002911, 100002916, 100002959, 100003001, 100003002, 100003003, 100003007, 100003044, 100003045, 100003047, 100003050, 100003051, 100003052, 100003081, 100003087, 100003088, 100003089, 100003149, 100003663, 100003670, 100003673, 100003684, 100003690, 100003691 and 475 more |
| Model numbers | V60 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1537-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.