Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 -…
Medical device recall Z-1990-2021. 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 728306 - Brilliance iCT 728311 - Brilliance iCT SP
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 System Code System Serial Number Unique Device Identifier (UDI#) 728306 100788 N/A 728306 100857 (01)00884838059474(21)100857 728306 100739 N/A 728306 100394 N/A 728306 100625 N/A 728306 100664 N/A 728306…
Every code shown here, 1,974 characters
Model/ Serial Number/UDI: N/A System Code System Serial Number Unique Device Identifier (UDI#) 728306 100788 N/A 728306 100857 (01)00884838059474(21)100857 728306 100739 N/A 728306 100394 N/A 728306 100625 N/A 728306 100664 N/A 728306 100764 (01)00884838059474(21)100764 728306 100280 N/A 728306 100782 (01)00884838059474(21)100782 728306 100830 (01)00884838059474(21)100830 728306 100410 N/A 728306 100413 N/A 728306 100788 N/A 728306 100322 N/A 728306 100374 N/A 728306 100327 N/A 728306 100463 N/A 728306 85033 N/A 728306 85104 N/A 728306 85125 (01)00884838059474(21)85125 728306 85095 (01)00884838059474(21)85095 728306 85018 N/A 728306 85013 N/A 728306 100400 N/A 728306 100402 N/A 728306 100405 N/A 728306 100509 N/A 728306 100331 N/A 728306 100375 N/A 728306 100056 N/A 728306 85019 N/A 728306 100657 N/A 728306 100415 N/A 728306 100507 N/A 728306 100450 N/A 728306 100386 N/A 728306 85113 (01)00884838059474(21)85113 728306 100281 N/A 728306 100441 N/A 728306 100346 N/A 728306 100300 N/A 728306 85039 N/A 728306 100348 N/A 728306 100347 N/A 728306 100345 N/A 728306 100490 N/A 728306 100667 N/A 728306 85054 N/A 728306 100335 N/A 728306 100404 N/A 728306 100604 N/A 728306 100408 N/A 728306 100317 N/A 728306 342002 N/A 728306 85219 (01)00884838059474(21)85219 728306 100682 N/A 728306 100313 N/A 728306 100332 N/A 728306 100092 N/A 728306 100163 N/A 728306 100646 N/A 728306 100714 N/A 728306 85031 N/A 728306 100411 N/A 728306 100720 N/A 728306 100610 N/A 728306 100653 N/A 728306 100517 N/A 728306 85101 (01)00884838059474(21)85101 728306 100632 N/A 728306 100062 N/A 728306 100288 N/A 728306 100365 N/A 728306 100169 N/A 728306 100858 (01)00884838059474(21)100858 728306 100446 N/A 728306 100813 (01)00884838059474(21)100813 728306 100729 N/A 728306 100601 N/A 728306 100205 N/A 728306 100038 N/A 728306 100302 N/A 728306 100723 N/A 728306 N/A 728306 100086 (01)00884838059474(21)100086 728306 100791 (01)00884838059474(21)100791 728306 100193 N/A 728306 85218…
FDA’s list runs to 4,782 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 4,782 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.