ClearanceBrief
Recall Z-0466-2026 ยท KPR System, X-Ray, Stationary

Philips Medical Systems DMC GmbH

Radiography 7300 C; Model Number: 712037;

DateNov 7, 2025 (initiated Oct 1, 2025)
StatusOpen, Classified
ReasonPhilips 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 causeDevice Design
ActionOn 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 th
Quantity284 units
DistributionWorldwide 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,
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K233662Radiography 7300 C
Philips Medical Systems Dmc GmbH, Jun 13, 2024