Z-0781-2024Class II

Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal...

Name: Z-0781-2024 Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal...
Creator: Sedecal Sa
Published: 2023-12-13
License: https://open.fda.gov/license/

Sedecal S.A. / initiated 2023-12-13 / Open, Classified / root cause: manufacturing process

FDA source

SEDECAL SA began a recall of 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... on 2023-12-13. FDA classified it as Class II and gives the reason as "Some parts have fallen off the equipment resulting in a safety risk to patients and/or users". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0781-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-13
Posted: 2024-01-23
Recalling firm: Sedecal S.A.
Product: 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.
Product code: KPR System, X-Ray, Stationary
Reason for recall: Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
Root cause tag: manufacturing process
FDA 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 involved. The letter included 3 attachments. Annex 1 contains further information regarding the issue. Annex 2 is the acknowledgement of receipt of the notification and understanding of the described problem and its importance. Annex 3 is confirmation that the mandatory field checks or upgrade of the affected unit is complete. The firm reported distributors will provide the information to the medical facility either by using the recalling firm's letter or creating a new letter.
Quantity in commerce: 845 units
Distribution: Distribution was made to AL, FL, and NC. There was no military/government distribution.
Product codes and lots: All serial numbers, UDI-DI 08436046002500.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0781-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0781-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-31	2024-01-22

Product code KPR

K012546Class IIOptima Urs Universal Radiographic SystemSedecal USA, Inc. / cleared 2001-11-02

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)