Philips Respironics, Inc. Recall 93015
Description: Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)
Philips Respironics, Inc. Recall 93015 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-2631-2023 |
Event ID | 93015 |
Event Description | Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines) |
Product Type | Devices |
Distribution | US Distribution to states of: OH, CA, SC, OR; and OUS country of: Philippines. |
Quantity | 15 (14 US; 1 OUS) |
Recall Reason | Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function. |
Device Classification | 20231004 |
Device Code Info | V60 Device Serial # /PCBA Serial # 201019564 SC23120K8 201014394 SC23120NH 201017048 SC2312133 100246411 SC231116C 100246416 SC231117H 100085632 SC2311127 100013579 SC23110EV 100082334 SC2311138 ***Updated November 6, 2023*** 100423818 SC2311168 100293267 SC2312154 100006900 SC2311165 100006889 SC23110MF 201010175 SC231104X (Philippines) ***Updated July 23, 2024*** 100385387 SC231108T 201029990 SC2311055 |
Center Classification Date | 20230928 |
Recall Initiation Date | 20230825 |
Recalling Firm | Philips Respironics, Inc. |
Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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