Recall Z-0781-2024 ยท KPR System, X-Ray, Stationary
SEDECAL SA
Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying position.
| Date | Jan 23, 2024 (initiated Dec 13, 2023) |
| Status | Open, Classified |
| Reason | Some parts have fallen off the equipment resulting in a safety risk to patients and/or users. |
| Root cause | Equipment maintenance |
| Action | On 12/13/2023, the recalling firm emailed the recall letter dated 12/11/2023 to their distributor customers along with attachments for service and maintenance of the units. The letter explained a description of the issue and that the installed devices should be inspected to ensure they are being used in a safe mode (the unit has been properly maintained and does not show any signs of the screws loosening) and to fix any potential issues. This inspection will also be included in all scheduled maintenance tasks to be performed in the future. The letter is to be distributed to all staff involv |
| Quantity | 845 units |
| Distribution | Distribution was made to AL, FL, and NC. There was no military/government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012546 | OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM Sedecal USA, Inc., Nov 2, 2001 |