Z-1003-2013Class II

Philips Healthcare Computed Tomography X-Ray System. These devices are whole-body computed tomography (CT)...

Name: Z-1003-2013 Philips Healthcare Computed Tomography X-Ray System. These devices are whole-body computed tomography (CT)...
Creator: Philips Healthcare Inc.
Published: 2010-04-05
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2010-04-05 / Terminated

FDA source

Philips Healthcare Inc. began a recall of Philips Healthcare Computed Tomography X-Ray System. These devices are whole-body computed tomography (CT) x-ray systems or sub-systems, each with a... on 2010-04-05. FDA classified it as Class II and gives the reason as "Philips Healthcare discovered the customer was performing CTDI measurements for facility accreditation and received results that were 15 to 25% higher than Philips protocol parameters stated". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1003-2013
Classification: Class II
Status: Terminated
Initiated: 2010-04-05
Posted: 2013-04-17
Terminated: 2021-03-08
Recalling firm: Philips North America LLC
Product: Philips Healthcare Computed Tomography X-Ray System. These devices are whole-body computed tomography (CT) x-ray systems or sub-systems, each with a continuously rotating x-ray tube and multi-row detectors enclosed by a gantry. X-ray transmission data acquired and taken at different angles can be reconstructed into cross-sectional images. Each device also includes signal analysis and display equipment, patient and equipment supports, components, and accessories.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Philips Healthcare discovered the customer was performing CTDI measurements for facility accreditation and received results that were 15 to 25% higher than Philips protocol parameters stated.
FDA root cause: Radiation Control for Health and Safety Act
Action: Philips Healthcare proposed corrective action plan (CAP) is comprised of the following elements: * Updating procedures in manufacturing to verify, either through software calibration or through gage-pin measurement, that A-plane collimation is appropriate to the design specification. It is our understanding that these procedures have been implemented. * For refurbished PET/CT and SPECT/CT systems distributed by Philips, the manufacturing process now requires that CTDI testing be conducted in addition to air testing and that each system meet updated CTDI tolerance limits to be published in the product's instructions for use. * Reassessing and correcting the correlation between air dose and CTDI specifications for all CT systems or sub-systems, resulting in updates of the CTDI specifications (tolerances) to be published in the instructions for use. It is our understanding that this reassessment and correction have been implemented, that the updated CTDI specifications will be made available as new CTDI tolerance tables with the customer information letter to be distributed immediately, and that these updated CTDI specifications will also be distributed as an addendum to the instructions for use manuals to the installed base during the next 12 months. * For all Brilliance CT, Gemini PET/CT, and Precedence SPECT/CT systems, in the installed base as well as in forward production, instructions for field service will be updated to provide clear directions on how to verify that the A-plane collimator has been appropriately adjusted to ensure expected product performance after its replacement and/or the replacement of an x-ray tube. This plan appears to adequately address the problem, and it is hereby approved. For further questions please call (978) 687-1501.
Quantity in commerce: 2089 US 4036 ROW
Distribution: Worldwide Distribution including USA (nationwide)
Product codes and lots: Gemini Dual, Gemini 16 Power, Gemini GXL, Gemini LXL, Gemini TF 16, Gemini TF Base/Ready, Gemini TF 64, Gemini TF Big Bore, Precedence SPECT/CT, Brilliance CT (6, 10,16, 16P, 40, 64, and Big Bore), Brilliance iCT, Brilliance iCT SP

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1003-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1003-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-17

Product code JAK

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)