Z-1137-2021Class II

PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 -

Name: Z-1137-2021 PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 -
Creator: Respironics California, LLC
Published: 2021-01-06
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2021-01-06 / Open, Classified / root cause: design

FDA source

Respironics California, LLC began a recall of 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... on 2021-01-06. FDA classified it as Class II and gives the reason as "Due to unqualified "design verification" batteries being shipped to customers". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1137-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-01-06
Posted: 2021-02-19
Recalling firm: Respironics, Inc.
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.
Product code: MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Reason for recall: Due to unqualified "design verification" batteries being shipped to customers.
Root cause tag: design
FDA 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 [email protected] 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 in commerce: 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.
Product codes and lots: Battery Model/Part Number: 1076374 Lot Code: M94663-P1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1137-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1137-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-03	2021-02-19

Product code MNT

K082660Class IIV60 Ventilator, Model V8000Respironics California, Inc. / cleared 2009-01-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)