Class 2 Device Recall Philips V60 Ventilator

• Date Initiated by Firm: January 06, 2021
• Create Date: February 19, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1137-2021
• Recall Event ID: 87314
• 510(K)Number: K082660
• Product Classification: Ventilator, continuous, minimal ventilatory support, facility use - Product Code MNT
• 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.
• Code Information: Battery Model/Part Number: 1076374 Lot Code: M94663-P1
• Recalling Firm/ Manufacturer: Respironics California, LLC; 2271 Cosmos Ct; Carlsbad CA 92011-1517
• For Additional Information Contact: 760-918-7300
• Manufacturer Reason for Recall: Due to unqualified "design verification" batteries being shipped to customers.
• FDA Determined 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 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MNT and Original Applicant = RESPIRONICS CALIFORNIA, INC.