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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93773

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

Open FDA event record

Event summary

Timeline bucket
December 15, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Philips North America

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

ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110

Z-1072-2024
Recall number
Z-1072-2024
Initiated
December 15, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America
Quantity
151 units; 138 units US; 13 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patient s radiography (RAD) images when starting the next patient scan while the previous patient image export is still processing. If the issue occurs, there is a potential for incorrect patient data to be displayed in the image. Issue 2: Detector Access point: Security vulnerability specific to the Wireless Portable Detector configuration items in Philips Support Connect (PSC). Due to this vulnerability it is possible, with physical access to the system and knowledge of specific settings, to modify and export data to removable media (example: USB)

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

Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patient s radiography (RAD) images when starting the next patient scan while the previous patient image export is still processing. If the issue occurs, there is a potential for incorrect patient data to be displayed in the image. Issue 2: Detector Access point: Security vulnerability specific to the Wireless Portable Detector configuration items in Philips Support Connect (PSC). Due to this vulnerability it is possible, with physical access to the system and knowledge of specific settings, to modify and export data to removable media (example: USB)

Code information

UDI: (1) 00884838085619 (2) 00884838103221 UDI: (1) 00884838085619 (2) 00884838103221 Serial Numbers US: (1) 10001064 10001065 10001066 10001067 10001068 10001069 10001070 10001072 10001073 10001074 10001075 10001076 10001077 10001078 10001079 10001084 10001085 10001086 10001087 10001088 10001089 10001090 10001091 10001092 10001093 10001096 10001098 10001099 10001100 10001101 10001102 10001104 10001105 10001107 10001108 10001109 10001110 10001111 10001112 10001113 10001114 10001116 10001117 10001120 10001121 10001125 10001128 10001129 10001130 10001132 10001135 10001136 10001137 10001138 10001139 10001140 10001141 10001142 10001143 10001144 10001145 10001149 10001150 10001152 10001153 10001157 10001158 10001159 10001160 10001161 1000116 (2) 20000026 20000061 20000062 20000068 20000078 20000079 20000086 SN10001002 SN10001003 SN10001004 SN18000002 SN18000006 SN18000013 SN18000018 SN18000024 SN19000007 SN19000017 Serial Numbers OUS: Serial Number 10000042 SN10001000 SN10001006 10001055 10001071 10001082 10001083 10001094 10001095 10001103 10001106 10001118 10001119 10001123 10001133 10001134 10001155. ***ADDED TO SCOPE 20 Nov 2024*** 1) SN18000003 SN18000017 SN18000022 SN19000005 2) Serial Number 10001147 10001115 10001156 (Germany) 10001166 10001167 10001168 10001173 10001174 10001175 10001176 10001177 10001180 10001201 10001204 10001206. REMOVED 20 Nov 2024. REF:706110 S/N: 10001055 10001071 10001082 10001083 10001094

Distribution pattern

Nationwide Foreign: Australia Germany India Italy Malaysia Panama Thailand

device · product 2 of 2

ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150

Z-1073-2024
Recall number
Z-1073-2024
Initiated
December 15, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America
Quantity
20 units: 16 units US; 4 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patients radiography (RAD) images when starting the next patient scan while the previous patient image export is still processing. If the issue occurs, there is a potential for incorrect patient data to be displayed in the image. Issue 2: Detector Access point: Security vulnerability specific to the Wireless Portable Detector configuration items in Philips Support Connect (PSC). Due to this vulnerability it is possible, with physical access to the system and knowledge of specific settings, to modify and export data to removable media (example: USB)

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

Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patients radiography (RAD) images when starting the next patient scan while the previous patient image export is still processing. If the issue occurs, there is a potential for incorrect patient data to be displayed in the image. Issue 2: Detector Access point: Security vulnerability specific to the Wireless Portable Detector configuration items in Philips Support Connect (PSC). Due to this vulnerability it is possible, with physical access to the system and knowledge of specific settings, to modify and export data to removable media (example: USB)

Code information

UDI: N/A Serial Numbers US: 4 5 6 7 8 9 11 12 13 14 17 18 61 692222229 692222254 692222263 Serial Numbers OUS: 53 56 65 692222227

Distribution pattern

Nationwide Foreign: Australia Germany India Italy Malaysia Panama Thailand