SEDECAL SA recalls
Every recall we track for SEDECAL SA — 53 in all, from 2021–2025 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
Recalls from SEDECAL SA more than tripled in 2025 (46, up from 1 in 2024). 2% rated “stop using now”.
All FDA recall records for SEDECAL SA since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 1 | 0 | 0 | 1 |
| 2022 | 1 | 0 | 0 | 0 | 1 |
| 2023 | 0 | 3 | 1 | 0 | 4 |
| 2024 | 0 | 1 | 0 | 0 | 1 |
| 2025 | 0 | 0 | 45 | 1 | 46 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled SEDECAL SA product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All SEDECAL SA recalls
7 shown- Lower riskMedical device
SEDECAL SA recalls MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system
SEDECAL recalls MobileDiagnost wDR 2.2 mobile X-ray systems (model REF 9890-010-89522) due to not being water-resistant. Users must clean strictly per manual to avoid damage.
SEDECALJun 10, 2025 - Use cautionMedical device
SEDECAL SA recalls Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b.
SEDECAL recalls Battery Mobile X-ray Unit EASY MOVING Model 3.1 with telescopic column 3.1 (model numbers SM-20HF-Batt to MobileDiagnost wDR) due to potential interference with anti-fall system. Affected units may not function safely during movement.
SEDECALJan 22, 2024 - Use cautionMedical device
SEDECAL SA recalls Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It
SEDEC: Sedecal X Optima URS digital mobile diagnostic x-ray system with falling parts poses safety risk to patients and users. Recall details and action steps provided.
SEDECALDec 13, 2023 - Lower riskMedical device
SEDECAL SA recalls wDR 2.2 Mobile Digital Diagnostic X-Ray System
SEDECAL recalls wDR 2.2 Mobile Digital Diagnostic X-Ray Systems with specific software versions that may prevent user login. Affected models include 712007, 712006, 712004, and 712002 with listed software versions. No remedy is provided in the recall notice.
SEDECALMay 23, 2023 - Use cautionMedical device
SEDECAL SA recalls Phoenix mKDR Xpress, digital mobile diagnostic x-ray system
SEDECAL recalls Phoenix mKDR Xpress digital mobile diagnostic x-ray systems due to reported erratic movements. Affected units have specific serial numbers and UDI/DI codes. Consumers should contact SEDECAL for details.
SEDECALFeb 6, 2023 - Stop using nowMedical device
SEDECAL SA recalls Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500
SEDECAL recalls Soltus 450 and 500 Battery Mobile X-Ray Systems due to uncommanded movement. Affected units have specific serial numbers and UDI codes. Stop using immediately to prevent potential injury.
SEDECALAug 12, 2022 - Use cautionMedical device
SEDECAL SA recalls MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
SEDECAL recalls MobileDiagnost wDR models 712001-712007 due to potential unintended movement if excessive liquid is used during cleaning, which could cause short circuits.
SEDECALOct 14, 2021
SEDECAL SA recall questions
How many recalls has SEDECAL SA had?
53 recalls from SEDECAL SA are on record with U.S. safety agencies, from 2021–2025.
What is the most recent SEDECAL SA recall?
SEDECAL SA recalls MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system, dated Jun 10, 2025. Every SEDECAL SA recall is listed on this page, newest first.
What should I do if I have a recalled SEDECAL SA product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new SEDECAL SA recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.