Reported Feb 21, 2024 · Ongoing
ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110
Philips North America
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America · 222 Jacobs St · Cambridge, MA · 02141-2296
Is this the product you have?
- ProxiDiagnost N90- A Multi-functional general Radiography
- and Fluoroscopy (R/F) system Ref(1)706100 (2)706110
- Lot codes and dates
- UDI(1) 00884838085619 (2) 00884838103221
- UDI(1) 00884838085619 (2) 00884838103221
- Serial Numbers US(1)(2)
71 of 71 codes
100010641000106510001066100010671000106810001069100010701000107210001073100010741000107510001076100010771000107810001079100010841000108510001086100010871000108810001089100010901000109110001092100010931000109610001098100010991000110010001101100011021000110410001105100011071000110810001109100011101000111110001112100011131000111410001116100011171000112010001121100011251000112810001129100011301000113210001135100011361000113710001138100011391000114010001141100011421000114310001144
20000026200000612000006220000068200000782000007920000086SN10001002SN10001003SN10001004SN18000002SN18000006SN18000013SN18000018SN18000024SN19000007
- SN19000017 Serial Numbers OUSSerial Number***ADDED TO SCOPE 20 Nov 2024*** 1) SN18000003 SN18000017 SN18000022 SN19000005 2) Serial Number 10001147 10001115 10001156 (Germany)
10000042SN10001000SN100010061000105510001071100010821000108310001094100010951000110310001106100011181000111910001123100011331000113410001155.
REMOVED 20 Nov 2024100011661000116710001168100011731000117410001175100011761000117710001180100012011000120410001206.
- REF706110
- S/N10001055 10001071 10001082 10001083 10001094
- Amount recalled
- 151 units; 138 units US; 13 units OUS
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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)
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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