Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93015

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 25, 2023
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Philips Respironics, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)

Z-2631-2023
Recall number
Z-2631-2023
Initiated
August 25, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Philips Respironics, Inc.
Quantity
15 (14 US; 1 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.

Code information

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

Distribution pattern

US Distribution to states of: OH, CA, SC, OR; and OUS country of: Philippines.

Field note

Send feedback

We'll only use this to respond to your feedback.