Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and…
Medical device recall Z-1983-2021. 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. BB (Big Bore) Oncology, BB (Big Bore) Radiology: 728242/728243/728244/728272 - Brilliance Big Bore
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 728242 20004 N/A 728242 768007 (01)00884838095168 728242 20013 N/A 728243 75107 N/A 728243 7729 N/A 728243 7786 N/A 728243 7741 N/A 728243 7820 N/A 728243 7892 N/A 728243 75027 N/A 728243 75029 N/A 728243 7941…
Every code shown here, 1,989 characters
Model/ Serial Number/UDI: N/A 728242 20004 N/A 728242 768007 (01)00884838095168 728242 20013 N/A 728243 75107 N/A 728243 7729 N/A 728243 7786 N/A 728243 7741 N/A 728243 7820 N/A 728243 7892 N/A 728243 75027 N/A 728243 75029 N/A 728243 7941 N/A 728243 75047 N/A 728243 7467 N/A 728243 7831 N/A 728243 7831 N/A 728243 7560 N/A 728243 75067 N/A 728243 7689 N/A 728243 7442 N/A 728243 75111 N/A 728243 7927 N/A 728243 7558 N/A 728243 7769 N/A 728243 7284 N/A 728243 75066 N/A 728243 7905 N/A 728243 7800 N/A 728243 7724 N/A 728243 7946 N/A 728243 7385 N/A 728243 7192 N/A 728243 7211 N/A 728243 7891 N/A 728243 75041 N/A 728243 7269 N/A 728243 7064 N/A 728243 7116 N/A 728243 7214 N/A 728243 7795 N/A 728243 7701 N/A 728243 7810 N/A 728243 7743 N/A 728243 75064 N/A 728243 75120 N/A 728243 750005 N/A 728243 750013 N/A 728244 760014 (01)00884838059450(21)760014 728244 760013 (01)00884838059450(21)760013 728244 76230 N/A 728244 76259 (01)00884838059450(21)76259 728244 76238 (01)00884838059450(21)76238 728244 76147 (01)00884838059450(21)76147 728244 76178 (01)00884838059450(21)76178 728244 7764 N/A 728244 760045 (01)00884838059450(21)760045 728244 760023 (01)00884838059450(21)760023 728244 75123 N/A 728244 760047 (01)00884838059450(21)760047 728244 76109 (01)00884838059450(21)76109 728244 760056 (01)00884838059450(21)760056 728244 7653 N/A 728244 76249 (01)00884838059450(21)76249 728244 76228 (01)00884838059450(21)76228 728244 76299 (01)00884838059450(21)76299 728244 7926 N/A 728244 7533 N/A 728244 7917 N/A 728244 76095 (01)00884838059450(21)76095 728244 7874 N/A 728244 7452 N/A 728244 76113 (01)00884838059450(21)76113 728244 76140 (01)00884838059450(21)76140 728244 76078 (01)00884838059450(21)76078 728244 7781 N/A 728244 76079 (01)00884838059450(21)76079 728244 760015 (01)00884838059450(21)760015 728244 760029 N/A 728244 760011 (01)00884838059450(21)760011 728244 7694 N/A 728244 76248 N/A 728244 7747 N/A 728244 7773 (01)00884838059450(21)7773 728244 7826 N/A 728244 76290…
FDA’s list runs to 2,298 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 2,298 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.