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Open, Classified

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.

FDA Recall Z-1137-2021 · Posted None

Recalling FirmRespironics California, LLC
Recall StatusOpen, Classified
Product CodeMNT
Date Initiated2021-01-06
Product Quantity94 batteries

Reason for Recall

Due to unqualified "design verification" batteries being shipped to customers.

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

Root Cause

Under Investigation by firm

Distribution Pattern

U.S. Nationwide distribution including in the states of FL, GA, IA, IA, IL. IL, MN, MO, NC, ND, OH, TX, TX and UT.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082660V60 VENTILATOR, MODEL V8000Respironics California, Inc. · 2009-01-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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