Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series… — Class II medical device recall Z-1208-2018
Terminated recall by Covidien LLC, reported 2018-04-04, distributed nationwide. Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Bennett 980 ventil
| Recall number | Z-1208-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LLC, North Haven, CT, United States |
| Recall initiated | 2017-11-21 |
| Classified | 2018-03-27 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2020-07-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, CA, CH, CL, CZ, DE, EE, EG, ES, FR, GB, GR, HR, HU, ID, IE, IL, IT, JO, KW, LB, LT, LV, MA, MX, MY, NL, NZ, PA, PH, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, TH, TN, TR, VN, ZA |
| Quantity | 15,885 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 20884521700861 |
| Serial numbers | 1349MM0001 |
Product
Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventilator, Universal Ventilator; Battery Product Number: 10086042; UDI: 20884521700861 The rechargeable lithium-ion batteries are intended to provide a backup power source to the ventilator in case AC power is lost.
Reason for recall
Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Bennett 980 ventilators may not fully charge after installation.
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-1208-2018. 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.