Z-1923-2020Class II

Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI #...

Name: Z-1923-2020 Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI #...
Creator: Philips North America, LLC
Published: 2020-04-06
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2020-04-06 / Terminated / root cause: manufacturing process

FDA source

Philips North America, LLC began a recall of Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI # (01)00884838059542(21)860067 on 2020-04-06. FDA classified it as Class II and gives the reason as "The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1923-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-06
Posted: 2020-05-06
Terminated: 2022-09-16
Recalling firm: Philips North America LLC
Product: Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI # (01)00884838059542(21)860067
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Philips sent a Medical Device Correction-Urgent Field Safety Notice dated April 6, 2020 to all affected customers. The firm instructed customers to review the information with all members of the staff who need to be aware of the contents of the notice and to maintain a copy with the equipment in the Instructions for Use. Customers were directed to complete and return the form stating that they received, read, and understood the contents of the letter and have taken appropriate actions. URGENT - Field Safety Notice Medical Device Correction letter dated 5/20/20 was sent to customers informing them of two additional affected systems. There is no action required by the customer. Testing and engineering analysis demonstrate that the under-torqued bolts do not pose any immediate safety risk as the mechanical connection between the cooling unit and the rotor continues to meet applicable safety standards. The affected systems may continue to be used according to the IFU. Philips is distributing this FSN to all affected customers/users and will correct the issue via Field Change Order FCO 72800725. Urgent Field Safety Notice Medical Device Correction dated 5/20/20 was distributed to notify additional systems not previously included in the original notification. There is no action required by the customer. Testing and engineering analysis demonstrate that the under-torqued bolts do not pose any immediate safety risk as the mechanical connection between the cooling unit and the rotor continues to meet applicable safety standards. The affected systems may continue to be used according to the IFU. Philips is distributing this FSN to all affected customers/users and will correct the issue via Field Change Order FCO 72800725. If you need any further information or support concerning this issue, please contact your local Philips representative: For North America, contact the Customer Care Solutions Center (1-800-722-9377, follow the prompts).
Quantity in commerce: 2
Distribution: Worldwide distribution including one unit distributed to Iowa.
Product codes and lots: Serial #s 860067, 860023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1923-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1921-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-06
Z-1922-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-06
Z-1923-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-06

Product code JAK

K193454Class IIIQon Spectral CTPhilips Medical Systems Nederland B.V. / cleared 2020-01-24

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)