Z-1329-2020Class II

CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 -

Name: Z-1329-2020 CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 -
Creator: Philips Medical Systems Gmbh, DMC
Published: 2019-12-19
License: https://open.fda.gov/license/

Philips Medical Systems DMC GmbH / initiated 2019-12-19 / Terminated / root cause: software

FDA source

Philips Medical Systems Gmbh, DMC began a recall of CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose on 2019-12-19. FDA classified it as Class II and gives the reason as "When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state, requiring the intervention of a service Engineer. Additionally, the thermos switch, which handles...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1329-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-19
Posted: 2020-02-20
Terminated: 2020-06-18
Recalling firm: Philips Medical Systems DMC GmbH
Product: CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state, requiring the intervention of a service Engineer. Additionally, the thermos switch, which handles power down of the unit in case of transformer overheating, was installed incorrectly at production.
Root cause tag: software
FDA root cause: Software design
Action: On December 19, 2019, the firm initiated mailing of the Medical Device Recall Letter to all affected customers. Customers were advised to use the system according to the Instructions for Use (IFU). In particular: Error 80 issue: The issue can be prevented if the operator avoids tilting the table by Table Up/Down joystick and instead uses the Table Tilt Left/Right joystick. If the issue occurs, the operator should remove the patient from the table and bring him/her to upright position so that the contrast agent does not enter the brain. SPDU issue: The user should pay attention to whether it smells of smoke in the room. If this is the case, immediately engage the system emergency stop button on the table or geometry control console, remove patient, stop using the system for further examinations and contact customer service. Philips plans to install a system software version upgrade and to perform an on-site check of the SPDU thermos contact at affected systems, which will eliminate these issues. A Philips Service Engineer will contact you when the Field Action Kit is available to be implemented. Should you need to communicate with Philips with regard to this program, please reference Field Change Order (FCO) 70900045 if you have a CombiDiagnost GCF system and FCO 70900048 if you have a CombiDiagnost PCF system. Technical Support Line: 1-800-722-9377.
Quantity in commerce: 131
Distribution: Worldwide distribution US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, MI, MN, MO, MT, NC, NJ, NY, OH, TX, UT, VA and countries of Canada, Australia, Austria, Bangladesh, Belgium, Bulgaria, Chile, China, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Dominican Republic, Egypt, Ethiopia, France, Germany, Ghana, Hungary, Iran, Italy, Jordan, Kenya, Kuwait, Latvia, Lebanon, Libya, Luxembourg, Malaysia, Martinique, Mexico, Nepal, Netherlands, New Zealand, Nigeria, Oman, Philippines, Poland, Portugal, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, South Africa, Spain, Switzerland, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Viet Nam.
Product codes and lots: (domestic only) SN374 SN17081704 SN17121782 SN18011800 SN18081862 SN18061846 SN18111907

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1329-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1328-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-02-26	2020-02-20
Z-1329-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-02-26	2020-02-20

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)