Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and…
Medical device recall Z-1982-2021. Published in FDA’s Enforcement Report on Jul 7, 2021.
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 Jul 7, 2021. 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
- 1,301 Monitor Bracket Assemblies total 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?
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 64, Brilliance 40, Ingenuity Flex 728235 - Brilliance 40 728231/728232 - Brilliance 64 728317/728318 - Ingenuity Flex
1,301 Monitor Bracket Assemblies total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model/ Serial Number/UDI: N/A 728235 90040 728235 90191 728235 90192 728235 90061 728235 29090 728235 90111 728235 29042 728235 90165 728235 29082 728235 29152 728235 90054 728235 90087 728235 90122 728235 90142 728235 90104 728235 90075…
Every code shown here, 1,998 characters
Model/ Serial Number/UDI: N/A 728235 90040 728235 90191 728235 90192 728235 90061 728235 29090 728235 90111 728235 29042 728235 90165 728235 29082 728235 29152 728235 90054 728235 90087 728235 90122 728235 90142 728235 90104 728235 90075 728235 9237 728235 90110 728235 90084 728235 90208 728235 9047 728235 90125 728235 90171 728235 90212 728235 90056 728235 90227 728235 90164 728235 90051 728235 90035 728231 9367 728231 95709 728231 10625 728231 10379 728231 9900 728231 10630 728231 10755 728231 10758 728231 90094.. 728231 9524 728231 95443 728231 95463 728231 90046 728231 95706 728231 95305 728231 10139 728231 29086 728231 10273 728231 95046 728231 95044 728231 95324 728231 90180 728231 95062 728231 95155 728231 95206 728231 95122 728231 95159 728231 90199 728231 95434 728231 95717 728231 95328 728231 95401 728231 10393 728231 90154 728231 95365 728231 95457 728231 95054 728231 95267 728231 95156 728231 95515 728231 10659 728231 10635 728231 29056 728231 95601 728231 95712 728231 95404 728231 90141 728231 90153 728231 95087 728231 95029 728231 90045 728231 95038 728231 90100 728231 95023 728231 95089 728231 90152 728231 90151 728231 64081 728231 10060 728231 90042 728231 90077 728231 95345 728231 9755 728231 90098 728231 9898 728231 9621 728231 9859 728231 90106 728231 10067 728231 9670 728231 9937 728231 9066 728231 10733 728231 90128 728231 9703 728231 9716 728231 9151 728231 9655 728231 10698 728231 9805 728231 10111 728231 9862 728231 9045 728231 10221 728231 10773 728231 9584 728231 9948 728231 95036 728231 9960 728231 90158 728231 9074 728231 95160 728231 95695 728231 10470 728231 29049 728231 9166 728231 90033 728231 95721 728231 10628 728231 29135 728231 95480 728231 9793 728231 29044 728231 9168 728231 95633 728231 9554 728231 9882 728231 9875 728231 10381 728231 10000 728231 9215 728231 95315 728231 95204 728231 10203 728231 10742 728231 10596 728231 90221 728231 95238 728231 90186 728231 10651 728231 10503 728231 10407 728231 10409 728231 90058 728231…
FDA’s list runs to 3,660 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.
Worldwide distribution - US Nationwide and the countries of Canada, Mexico, AE, AR, AT, AU, BD, BE, BR, CH, CL, CN, CO, CU, CY, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GE, GI, GL, GR, HK, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KG, KH, KR, LA, LB, LK, LT, LY, MM, MN, MU, MV, MY, NI, NL, NO, NZ, OM, PA, PF, PH, PK, PL, PS, PT, QA, RE, RU, RW, SA, SE, SG , SI, SK, TH, TN, TR, UZ, VN, XK, YE, ZA, ZW.
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 May 1, 2021.
- FDA classified it on Jun 30, 2021.
- FDA’s Enforcement Report published it on Jul 7, 2021.
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 3,660 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
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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.