Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon…
Medical device recall Z-1985-2021. 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 728332 - IQon Spectral CT : IQon Spectral CT
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 728332 860005 N/A 728332 395001 N/A 728332 860043 (01)00884838059542(21)860043 728332 860131 (01)00884838059542(21)860131 728332 860050 (01)00884838059542(21)860050 728332 860122 (01)00884838059542(21)860122…
Every code shown here, 1,999 characters
Model/ Serial Number/UDI: N/A 728332 860005 N/A 728332 395001 N/A 728332 860043 (01)00884838059542(21)860043 728332 860131 (01)00884838059542(21)860131 728332 860050 (01)00884838059542(21)860050 728332 860122 (01)00884838059542(21)860122 728332 60038 (01)00884838059542(21)60038 728332 860177 N/A 728332 860185 (01)00884838059542(21)860185 728332 860172 (01)00884838059542(21)860172 728332 60051 (01)00884838059542(21)60051 728332 60009 N/A 728332 860098 (01)00884838059542(21)860098 728332 60054 (01)00884838059542(21)60054 728332 860199 (01)00884838059542(21)860199 728332 860123 (01)00884838059542(21)860123 728332 860059 (01)00884838059542(21)860059 728332 860199 N/A 728332 860015 N/A 728332 860014 N/A 728332 860096 (01)00884838059542(21)860096 728332 860029 N/A 728332 860073 (01)00884838059542(21)860073 728332 860058 (01)00884838059542(21)860058 728332 860082 (01)00884838059542(21)860082 728332 860069 (01)00884838059542(21)860069 728332 860216 (01)00884838059542(21)860216 728332 860193 (01)00884838059542(21)860193 728332 860118 (01)00884838059542(21)860118 728332 860024 N/A 728332 860204 (01)00884838059542(21)860204 728332 60066 N/A 728332 860154 N/A 728332 860175 (01)00884838059542(21)860175 728332 860186 (01)00884838059542(21)860186 728332 860038 N/A 728332 860078 (01)00884838059542(21)860078 728332 60042 (01)00884838059542(21)60042 728332 860110 (01)00884838059542(21)860110 728332 860027 (01)00884838059542(21)860027 728332 860071 (01)00884838059542(21)860071 728332 860139 (01)00884838059542(21)860139 728332 60014 (01)00884838059542(21)60014 728332 N/A 728332 60040 (01)00884838059542(21)60040 728332 860153 (01)00884838059542(21)860153 728332 860103 (01)00884838059542(21)860103 728332 860075 (01)00884838059542(21)860075 728332 860181 (01)00884838059542(21)860181 728332 860012 N/A 728332 860046 (01)00884838059542(21)860046 728332 860152 (01)00884838059542(21)860152 728332 860054 (01)00884838059542(21)860054 728332 860140 (01)00884838059542(21)860140 728332 860020 N/A…
FDA’s list runs to 3,073 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 3,073 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.