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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93218

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 09, 2023
Product types
Device
Classifications
Class II
Statuses
Completed
Recalling firm wording
Philips Ultrasound, 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

2 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 2

Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 795202), EPIQ 5G (model # 795204), EPIQ 5W (model # 795206), EPIQ CVx (Model # 795231), EPIQ Elite (model # 795234)

Z-0283-2024
Recall number
Z-0283-2024
Initiated
October 09, 2023
Classification
Class II
Status
Completed
Recalling firm
Philips Ultrasound, Inc.
Quantity
83 systems

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software version 10.0 may

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image.

Code information

Following model numbers and serial numbers operating with software version 10.0: Model 795200/UDI:(01)00884838047693/Serial numbers: US818B1520 US115B0264 USD14B0996 USN18B0465 US915B0649 US516B0839 US516B0840 US516B0841 US617B1185 US617B1186 US617B1187 US318B2182 USN19B1084 USD13B0543 US419B1858 US419B1860 US419B1949; Model 795201/UDI:(01)00884838047693/Serial Number: USN16B0579; Model # 795202/UDI: (01)00884838047693/ Serial Numbers: US416B1186 US813B0429 US813B0430 US813B0432 USD16B1124 USD16B1126 USD16B1129 US419B1141 US419B1142 US419B1143 US419B1289 USO18B1195; Model 795204/ UDI: (01)00884838047686/ Serial Numbers: US220C0963 US818C1422 US818C1432 US818C1433 US818C1434 US719C0684; model # 795206/ UDI: (01)00884838047686/ Serial Numbers: USD16C1116 USD17C0754 USD18C0039 USO15C0951 US320C0864 Model # 795231/ UDI: (01)00884838114135/ Serial numbers: US723B1124 US120B0345 US120B0348 US120B1131 US723B1125 US723B1121 US723B1122 US723B1123; Model # 795234/UDI: (01)00884838107540/ Serial numbers: USO22B0941 US322B0678 US322B0676 US723B1023 US723B1126 US723B1024 US723B1022 US723B1128 US723B1127 US423B1238 US723B1021 US521B1455 US723B1017 US323B2026 US723B1018 US723B1019 US223B1718 US223B1719 US223B1720 USD22B0063 US323B0675 US723B1020 US523B0298 US523B0299 US523B0300 US523B2699 US523B2700 US523B2701 US523B2702 US523B2703 US523B2704 US523B2705 US523B2873 US523B2872

Distribution pattern

US: AZ, CA, CT, FL, GA, ID, IL, KY, MD, MT, NE, NV, OH, TN, TX, UT, VA OUS: Canada

device · product 2 of 2

Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210

Z-0284-2024
Recall number
Z-0284-2024
Initiated
October 09, 2023
Classification
Class II
Status
Completed
Recalling firm
Philips Ultrasound, Inc.
Quantity
7 systems

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software version 10.0 may

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image.

Code information

Following serial numbers operating with software version 10.0. Model 795210/UDI: (01)00884838106611/Serial Numbers: US523F1930 US918F1158 US918F1159 US723F1377 US523F1496 US523F1497 US217F0292

Distribution pattern

US: AZ, CA, CT, FL, GA, ID, IL, KY, MD, MT, NE, NV, OH, TN, TX, UT, VA OUS: Canada