Z-0376-2017Class II

Philips Healthcare System X-ray Tomography Computed

Name: Z-0376-2017 Philips Healthcare System X-ray Tomography Computed
Creator: Philips Electronics North America Corporation
Published: 2016-03-15
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2016-03-15 / Terminated

FDA source

Philips Electronics North America Corporation began a recall of Philips Healthcare System X-ray Tomography Computed on 2016-03-15. FDA classified it as Class II and gives the reason as "It was discovered the patient support tabletop may fail to move in the horizontal direction when it is commanded to do so during CT scans due to a potential mechanical linkage failure". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0376-2017
Classification: Class II
Status: Terminated
Initiated: 2016-03-15
Posted: 2016-11-22
Terminated: 2020-09-09
Recalling firm: Philips North America LLC
Product: Philips Healthcare System X-ray Tomography Computed :
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: It was discovered the patient support tabletop may fail to move in the horizontal direction when it is commanded to do so during CT scans due to a potential mechanical linkage failure.
FDA root cause: Radiation Control for Health and Safety Act
Action: Philips planned action: 1. Philips issued a customer notification letter on October 13, 2016. The letter includes a statement that the corrections will be made free of charge. 2. Philips will initiate a field corrective action to address the issue. 3. Philips will contact the customer and schedule an inspection to determine if the unit requires repair. 4. If repair is required, the couch horizontal linkage assembly will be replaced. For further questions please call (978) 659-3000.
Quantity in commerce: 1363
Distribution: USA(nationwide) Distribution to the states of : AZ, NY, GA, UT, TN, TX, AR, NV, Il, FL, MS, LA, MD, MO, MA, OK, KY, WY, SC, ND, NE, DE, MI, WA, CT, RI, KS, OR, IN, PA, CA, NJ, NC, MN, AL and IA.
Product codes and lots: Ingenuity CT, Ingenuity Core, Ingenuity Core 128.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0376-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0375-2017	Class II	Terminated	FDA Mandated	2016-11-30	2016-11-22
Z-0376-2017	Class II	Terminated	FDA Mandated	2016-11-30	2016-11-22

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)