Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy
Medical device recall Z-1382-2023. Published in FDA’s Enforcement Report on Apr 19, 2023.
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 Apr 19, 2023. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 2 states named
- US: 10 units; OUS: 570 units 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?
If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of the telescopic carriage will unavoidably decay through normal wear and tear; as a result there is a potential that the Ceiling Suspension of the DigitalDiagnost C50 system may descend inadvertently if power to the system is interrupted, and may result in injuries to patients and users
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201
US: 10 units; OUS: 570 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: (01)00884838082366(21) US: Serial Numbers: 200072 200131 200132 200143 SN170053 SN180074 SN180163 SN180181 SN180182 SN190119 OUS: 200004 200005 200006 200011 200014 200015 200031 200039 200040 200041 200043 200046 200047 200048…
Every code shown here, 1,996 characters
UDI-DI: (01)00884838082366(21) US: Serial Numbers: 200072 200131 200132 200143 SN170053 SN180074 SN180163 SN180181 SN180182 SN190119 OUS: 200004 200005 200006 200011 200014 200015 200031 200039 200040 200041 200043 200046 200047 200048 200050 200054 200058 200059 200060 200061 200062 200063 200064 200065 200067 200068 200069 200070 200072 200073 200074 200075 200077 200078 200079 200080 200081 200082 200083 200085 200087 200089 200090 200091 200092 200093 200095 200096 200098 200099 200100 200101 200102 200103 200104 200105 200106 200107 200108 200109 200110 200112 200113 200114 200115 200116 200117 200118 200119 200120 200121 200122 200123 200124 200125 200130 200131 200132 200133 200134 200135 200138 200141 200143 200144 200146 200147 210001 210003 210007 210008 210009 210010 210011 210013 210014 210016 SN160004 SN160005 SN160006 SN160007 SN160008 SN160009 SN160011 SN160012 SN160013 SN160014 SN160015 SN160016 SN170001 SN170002 SN170003 SN170004 SN170005 SN170007 SN170008 SN170009 SN170010 SN170014 SN170015 SN170016 SN170017 SN170018 SN170019 SN170020 SN170021 SN170022 SN170023 SN170024 SN170025 SN170028 SN170029 SN170030 SN170031 SN170032 SN170033 SN170034 SN170035 SN170036 SN170037 SN170038 SN170039 SN170040 SN170041 SN170042 SN170043 SN170044 SN170045 SN170046 SN170048 SN170049 SN170050 SN170052 SN170054 SN170055 SN170056 SN170057 SN170058 SN170060 SN170061 SN170062 SN170063 SN170066 SN170067 SN170068 SN170069 SN170070 SN170071 SN170072 SN170073 SN170075 SN170076 SN170078 SN170081 SN170082 SN170083 SN170084 SN170085 SN170086 SN170087 SN170088 SN170091 SN170093 SN170097 SN170104 SN170106 SN170109 SN170111 SN170112 SN170114 SN170116 SN170118 SN170128 SN170131 SN170132 SN180006 SN180007 SN180008 SN180009 SN180010 SN180011 SN180012 SN180014 SN180015 SN180016 SN180017 SN180018 SN180019 SN180020 SN180021 SN180022 SN180023 SN180024 SN180025 SN180028 SN180029 SN180030 SN180031 SN180032 SN180033 SN180034 SN180035 SN180036 SN180038 SN180039 SN180040 SN180041 SN180043…
FDA’s list runs to 5,109 characters. The first part is shown; the rest is on FDA’s record.
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 including Puerto Rico and Virgin Islands Foreign: ARGENTINA Australia Austria Bosnia and Herzegovina Bulgaria China Colombia Cyprus Czech Republic Egypt France French Polynesia Germany Greece Hungary Indonesia Italy Jordan Kenya Latvia Lithuania Macedonia Malta Mexico Netherlands New Zealand Philippines Poland Portugal Puerto Rico Russian Federation Saudi Arabia Serbia Slovenia South Africa Spain Sri Lanka Switzerland Tanzania Thailand United Arab Emirates Viet Nam Yemen
The states and territories these words name
- Puerto Rico
- US Virgin Islands
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 Mar 9, 2023.
- FDA classified it on Apr 12, 2023.
- FDA’s Enforcement Report published it on Apr 19, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips North America Llc, 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.”
- FDA’s list of codes runs to 5,109 characters; the first part is shown here, and the rest is on FDA’s record.
- 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
-
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.