Z-0463-2026Class II

Precision CRF; Model Number: 706400

Name: Z-0463-2026 Precision CRF; Model Number: 706400
Creator: Philips Medical Systems DMC GmbH
Published: 2025-10-01
License: https://open.fda.gov/license/

Philips Medical Systems DMC GmbH / initiated 2025-10-01 / Open, Classified / root cause: design

FDA source

Philips Medical Systems DMC GmbH began a recall of Precision CRF; Model Number: 706400 on 2025-10-01. FDA classified it as Class II and gives the reason as "Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0463-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-01
Posted: 2025-11-07
Recalling firm: Philips Medical Systems DMC GmbH
Product: Precision CRF; Model Number: 706400;
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.
Root cause tag: design
FDA root cause: Device Design
Action: On October 1, 2025, "URGENT MEDICAL DEVICE CORRECTION" letters dated September 30, 2025, were sent to customers. The letters described the problem, product and actions to be taken. Actions to be taken: It is safe to continue to use the system(s) in accordance with the intended use. It is recommended that customers use the motorized movement option until the technical solution has been implemented. The system may experience motor drive errors if the force for movement exceeds 110N, which restricts the motorized movement. If the motorized movement does not function, customers should contact their local service representative. B. Circulate this notice to all users of this device so that they are aware of the issue and associated hazard/harm. C. Please retain this Urgent Medical Device Correction letter with your system(s) until the solution is installed; ensure the notice is in a place likely to be seen/viewed. 5. Actions planned by Philips to correct the problem. Philips will provide the technical solution details when finalized. This notice has been reported to the appropriate Regulatory Agencies. 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, 8AM 8PM EST, Monday-Friday).
Quantity in commerce: 42 units
Distribution: Worldwide Distribution: US (Nationwide) Distribution and OUS (International) countries of: Australia, Austria, Bahrain, Belgium, Bosnia-Herz., Canada, Chile, Croatia, Denmark, Estonia, Finland, France, Germany, Ghana, Gibraltar, Guadeloupe, Indonesia, Iraq, Israel, Italy, Jordan, Kuwait, Kyrgyzstan, Latvia, Lithuania, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, R¿union, Samoa, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, T¿rkiye, Turkmenistan, United Kingdom, Utd.Arab.Emir.,
Product codes and lots: Model Number: 706400; UDI-DI: 00884838110588; Serial Number: 19, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 10001178, 10001179, 10001181, 10001182, 10001184, 10001185, 10001186, 10001187, 10001188, 10001189, 10001190, 10001191, 10001192, 10001193, 10001194, 10001195, 10001196, 10001197, 10001199, 10001200, 10001201, 10001202, 10001203, 10001204, 10001205, 10001206, 10001208, 10001209;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0463-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0461-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-07
Z-0462-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-07
Z-0463-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-07
Z-0464-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-07
Z-0465-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-07
Z-0466-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-07

Product code JAA

K233945Class IIProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH / cleared 2024-01-11

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)