Z-1986-2021Class II

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333 - Spectral CT

Name: Z-1986-2021 Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333 - Spectral CT
Creator: Philips North America Llc
Published: 2021-05-01
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2021-05-01 / Open, Classified / root cause: design

FDA source

Philips North America Llc began a recall of Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333 - Spectral CT on 2021-05-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1986-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-05-01
Posted: 2021-06-30
Recalling firm: Philips North America LLC
Product: Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333 - Spectral CT:
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: Philips issued URGENT- Field Safety Notice Medical Device Correction letter on 5/1/21 FSN 72800751 and FSN 88200530 . Letter states reason for recall, health risk and action to take: " Be aware of this hazard when the safety clip is missing from the joint assembly between the Monitor Bracket Assembly and the Ceiling Suspension Arm. " Inspect the joint area of their CCT DVI Ceiling Mount Arm (the circled area in picture at theright) and observe that the safety clip is installed (as depicted in pictures below). " When this hazard occurs, the monitor may become difficult to rotate relative to the Suspension Arm. When these symptoms are recognized, in order to avoid the occurrence of a hazardous situation, take the following actions: stop using the suspension monitor clinically move the monitor arm away from any person call Philips Service for repairs. Please acknowledge the receipt of this notice by completing, signing, and returning the form attached at the end of this communication to the indicated email address. Philips will inspect systems via Field Change Order FCO 88200530. Systems failing the inspection will be corrected via Field Change Order FCO 882531 For North America, contact the Customer Care Solutions Center (1-800-722-9377, follow the prompts).
Quantity in commerce: 1,301 Monitor Bracket Assemblies total
Distribution: 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.
Product codes and lots: Model/ Serial Number/UDI: N/A 10016 (01)00884838101111(21)10016 10018 (01)00884838101111(21)10018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1986-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1979-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-07	2021-06-30
Z-1980-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-07	2021-06-30
Z-1981-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-07	2021-06-30
Z-1982-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-07	2021-06-30
Z-1983-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-07	2021-06-30
Z-1984-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-07	2021-06-30
Z-1985-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-07	2021-06-30
Z-1986-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-07	2021-06-30
Z-1987-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-07	2021-06-30
Z-1988-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-07	2021-06-30
Z-1989-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-07	2021-06-30
Z-1990-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-07	2021-06-30

Product code JAK

K203020Class IISpectral CTPhilips Medical Systems Nederland B.V. / cleared 2021-02-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)