Z-0330-2018Class II

CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-functional general...

Name: Z-0330-2018 CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-functional general...
Creator: Philips Electronics North America Corporation
Published: 2017-10-19
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2017-10-19 / Terminated / root cause: manufacturing process

FDA source

Philips Electronics North America Corporation began a recall of CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine... on 2017-10-19. FDA classified it as Class II and gives the reason as "The tube adapter-plate green/yellow protective earthing (PE) wire was removed. and spacers with different thickness were used to position pre-loc ring in respect to focal spot in specified distance". 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-0330-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-19
Posted: 2018-01-10
Terminated: 2018-09-20
Recalling firm: Philips North America LLC
Product: CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: The tube adapter-plate green/yellow protective earthing (PE) wire was removed. and spacers with different thickness were used to position pre-loc ring in respect to focal spot in specified distance.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Philips Medical System sent an Customer Notification letter dated October 19, 2017, and plans to have a Philips Field Service Engineer go to site to perform the field change order (FCO70900041) including: 1. Check for the presence of the PE cable and, if missing, install it. 2 .Perform a modified screw fixation. They expect to complete action by May 2018. For further questions, please call (978) 659-3000.
Quantity in commerce: 10
Distribution: Worldwide Distribution - US Distribution and to the countries of : France, Germany, Luxembourg and New Zealand.
Product codes and lots: All CombiDiagnost R90 UDI 709030

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0330-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0330-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-17	2018-01-10

Product code JAA

K163210Class IIPhilips CombiDiagnost R90Philips Medical Systems Dmc GmbH / cleared 2017-01-31

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)