CLASS II ONGOING Device recall · Reported 31 Jan 2024 · FDA Enforcement Report
X Optima URS digital mobile diagnostic x-ray system recalled by Sedecal
Sedecal is recalling Sedecal X Optima URS digital mobile diagnostic x-ray system, distributed in Alabama, Florida, North Carolina. The recall was initiated on 13 Dec 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0781-2024
- FDA event ID
- 93614
- Recalling firm
- Sedecal, Algete, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Dec 2023
- FDA classified
- 22 Jan 2024
- Reported
- 31 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 13 Dec 2023 | Recall initiated by company | |
| 22 Jan 2024 | Classified by FDA | +40 days |
| 31 Jan 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
Product as listed by the FDA
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.
Where it was distributed
Distribution was made to AL, FL, and NC. There was no military/government distribution.
Questions about this recall
Is X Optima URS digital mobile diagnostic x-ray system recalled?
Yes. Sedecal recalled X Optima URS digital mobile diagnostic x-ray system on 13 Dec 2023. The recall is Class II and its status is Ongoing. Recall number Z-0781-2024.
Why was it recalled?
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
Which lots are affected?
All serial numbers, UDI-DI 08436046002500.
Where was it sold?
Distribution was made to AL, FL, and NC. There was no military/government distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Sedecal
All 57| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Model Number SM-40HF-B-d-c; 40KW Canon Ready, Mobile X-ray system recalled | Sedecal | Other | CA, IL, NJ |
| Device | CLASS II | Model SM-32HF-Batt; 32KW Analog, Mobile X-ray system recalled by Sedecal | Sedecal | Other | CA, IL, NJ |
| Device | CLASS II | Model Number SM-40HF-B-d-c; 40KW70CDEMO.005, Mobile X-ray system recalled | Sedecal | Other | CA, IL, NJ |
| Device | CLASS II | Model Number 40KWFX, Mobile X-ray system recalled by Sedecal | Sedecal | Other | CA, IL, NJ |
| Device | CLASS II | Model Number SM-40HF-B-d-c; 40KW 50G, Mobile X-ray system recalled | Sedecal | Other | CA, IL, NJ |
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