FDA Medical Device Recalls (openFDA)
Respironics California, LLC: PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
- Recall number
- Z-1137-2021
- Recalling firm
- Respironics California, LLC
- Product
- PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
- Status
- Open, Classified
- Initiated
- 2021-01-06
- Posted
- not on file
- Terminated
- not on file
- Reason
- Due to unqualified "design verification" batteries being shipped to customers.
- Root cause
- Under Investigation by firm
- Action
- On 01/06/2021, the firm contacted via telephone calls and then on 01/29/2021 sent a follow-up "URGENT - Medical Device Removal" letter via priority mail to customers to inform them that the Recalling Firm shipped unqualified batteries to customers. These batteries are similar to production batteries but did complete final qualification testing. Potential hazards that may result, In a worst-case scenario, a battery failure could occur while in use on a patient during intra-hospital transport or when not connected to AC power. In both situations, the patient could lose ventilatory assistance and experience severe hypoxemia. Customers are provided instructions on how to identify affected products: Check the label of backup batteries (PN 1076374) received on or after November 25, 2020, or installed on affected units. If the battery has LOT M94663-P1, it is affected. Customers are instructed to: 1. If the batteries have been installed in ventilators, remove the ventilators from service until a field service representative or approved service provider schedules a visit and replaces the battery. 2. If waiting for a field service representative or approved service provider is not possible given their current census, contact Recalling Firm by email at HRC.Recall.Response@Philips.com to request a replacement battery that trained biomed can install. 3. If the affected battery has not been installed in a ventilator, quarantine the battery until a Recalling Firm representative can replace it. 4. Complete, sign, and return the Acknowledgment and Receipt Form at the end of this letter. For further information and questions - contact the local representatives or Customer Care Solutions Center (24/7) +1-800-722-9377
- Quantity
- 94 batteries
- Distribution
- U.S. Nationwide distribution including in the states of FL, GA, IA, IA, IL. IL, MN, MO, NC, ND, OH, TX, TX and UT.
- Lot, serial or model codes
- Battery Model/Part Number: 1076374 Lot Code: M94663-P1
- 510(k) numbers
- ["K082660"]
- PMA numbers
- not on file
- Product code
- MNT
- Firm FEI
- 2518422
- Firm city
- Carlsbad
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28