Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128,…
Medical device recall Z-1984-2021. 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 Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity 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 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT 728321 52051 N/A 728321 52113 (01)00884838059498(21)52113 728321 52105 (01)00884838059498(21)52105 728321 52106…
Every code shown here, 2,000 characters
Model/ Serial Number/UDI: N/A 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT 728321 52051 N/A 728321 52113 (01)00884838059498(21)52113 728321 52105 (01)00884838059498(21)52105 728321 52106 (01)00884838059498(21)52106 728321 333121 N/A 728321 52018 N/A 728321 310113 N/A 728321 310114 N/A 728321 310128 N/A 728321 310162 N/A 728321 333024 N/A 728321 52159 (01)00884838059498(21)52159 728321 52129 N/A 728321 333078 N/A 728321 52079 N/A 728321 52052 N/A 728321 333057 N/A 728321 333059 N/A 728321 941164 N/A 728321 333132 N/A 728321 333146 N/A 728321 30025 N/A 728321 333043 N/A 728321 333150 N/A 728321 333071 N/A 728321 52110 (01)00884838059498(21)52110 728321 333159 (01)00884838059498(21)333159 728321 52020 N/A 728321 310063 N/A 728321 310141 N/A 728321 310133 N/A 728321 52153 (01)00884838059498(21)52153 728321 333151 N/A 728321 333060 N/A 728321 310377 (01)00884838059498(21)310377 728321 333094 N/A 728321 310059 N/A 728321 333135 N/A 728321 333074 N/A 728321 52046 N/A 728321 52046 N/A 728321 52036 N/A 728321 52029 N/A 728321 52037 N/A 728321 52034 N/A 728321 52035 N/A 728321 310385 (01)00884838059498(21)310385 728321 52108 (01)00884838059498(21)52108 728321 333196 (01)00884838059498(21)333196 728321 310119 N/A 728321 52086 (01)00884838059498(21)52086 728321 310036 N/A 728321 333195 (01)00884838059498(21)333195 728321 310157 N/A 728321 333149 N/A 728321 342002 (01)00884838059498(21)342002 728321 333062 N/A 728321 52165 (01)00884838059498(21)52165 728321 52089 (01)00884838059498(21)52089 728321 333006 N/A 728321 310023 N/A 728321 310087 N/A 728321 333114 N/A 728321 333013 N/A 728321 333053 N/A 728321 310289 N/A 728321 310344 (01)00884838059498(21)310344 728321 310308 N/A 728321 310350 (01)00884838059498(21)310350 728321 310262 N/A 728321 310401 (01)00884838059498(21)310401 728321 310346 (01)00884838059498(21)310346 728321 310250 N/A 728321 52144 (01)00884838059498(21)52144 728321 333009 (01)00884838059498(21)333009 728321 310316 N/A 728321…
FDA’s list runs to 15,511 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 15,511 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.