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Respironics California, LLC Recall 87314

Description: 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.

Respironics California, LLC Recall 87314 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1137-2021
Event ID87314
Event DescriptionPHILIPS 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 TypeDevices
DistributionU.S. Nationwide distribution including in the states of FL, GA, IA, IA, IL. IL, MN, MO, NC, ND, OH, TX, TX and UT.
Quantity94 batteries
Recall ReasonDue to unqualified "design verification" batteries being shipped to customers.
Device Classification20210303
Device Code InfoBattery Model/Part Number: 1076374 Lot Code: M94663-P1
Center Classification Date20210219
Recall Initiation Date20210106
Recalling FirmRespironics California, LLC
Initial Notification Letter
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