ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system
Medical device recall Z-1072-2024. Published in FDA’s Enforcement Report on Feb 21, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Feb 21, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 151 units; 138 units US; 13 units OUS how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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)
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110
151 units; 138 units US; 13 units OUS, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,440 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide Foreign: Australia Germany India Italy Malaysia Panama Thailand
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 15, 2023.
- FDA classified it on Feb 9, 2024.
- FDA’s Enforcement Report published it on Feb 21, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips North America, of Cambridge, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.