FDA Device recall Z-1208-2018
Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventil…
- FDA Device
- Class II
- terminated
- Published 2018-04-04
On 2018-04-04 the FDA classified a Class II recall of Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventil… by Covidien, citing rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Bennett 980 ventilators may not fully charge after installation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1208-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-21 |
| Published | 2018-04-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Covidien |
| Distribution | US |
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
Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Bennett 980 ventilators may not fully charge after installation.
Identifiers
| code_info | Serial Numbers: 1349MM0001 UDI: 20884521700861 1349MM0002 1349MM0003 1349MM0004 1349MM0005 1349MM0006 1349MM000…Serial Numbers: 1349MM0001 UDI: 20884521700861 1349MM0002 1349MM0003 1349MM0004 1349MM0005 1349MM0006 1349MM0007 1349MM0008 1349MM0009 1349MM0010 1349MM0011 1349MM0012 1349MM0013 1349MM0014 1349MM0015 1349MM0016 1349MM0017 1349MM0018 1349MM0019 1349MM0020 1349MM0021 1349MM0022 1349MM0023 1349MM0024 1349MM0025 1349MM0026 1349MM0027 1349MM0028 1349MM0029 1349MM0030 1349MM0031 1349MM0032 1349MM0033 1349MM0034 1349MM0035 1349MM0036 1349MM0037 1349MM0038 1349MM0039 1349MM0040 1349MM0041 1349MM0042 1349MM0043 1349MM0044 1349MM0045 1349MM0046 1349MM0047 1349MM0048 1349MM0049 1349MM0050 1349MM0051 1349MM0052 1349MM0053 1349MM0054 1349MM0055 1349MM0056 1349MM0057 1349MM0058 1349MM0059 1349MM0060 1349MM0061 1349MM0062 1349MM0063 1349MM0064 1349MM0065 1349MM0066 1349MM0067 1349MM0068 1349MM0069 1349MM0070 1349MM0071 1349MM0072 1349MM0073 1349MM0074 1349MM0075 1349MM0076 1349MM0077 1349MM0078 1349MM0079 1349MM0080 13 |
|---|
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-1208-2018%22
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