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.
Potential interference with the anti-fall system.
SEDECAL is recalling Battery Mobile X-ray Units with telescopic column 3.1 model numbers SM-20HF-Batt through MobileDiagnost wDR. The units could interfere with their own anti-fall system, potentially causing a fall during movement.
The anti-fall system may not work properly during movement, increasing the risk of the unit tipping over. This could lead to injuries for people nearby, especially in healthcare settings where the unit is moved frequently.
Healthcare facilities using these mobile X-ray units are most at risk. Patients and staff could be affected if the unit tips over during movement due to anti-fall system failure.
Check for model numbers SM-20HF-Batt, SM-32HF-Batt, SM-40HF-Batt, SM-50HF-Batt, SM-40-HF-B-D-VIR, SM-20HF-B-D-KM, SM-32-HF-B-D-KM, SM-40HF-B-D-KM, or SM-50HF-B-D-KM on the unit. The units are labeled as 'Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1'.
Look for model numbers SM-20HF-Batt through SM-50HF-B-D-KM on the unit's label or documentation.
If you cannot confirm the model number, stop using the unit until you can verify it is not affected.
Model numbers SM-20HF-Batt, SM-32HF-Batt, SM-40HF-Batt, SM-50HF-Batt, SM-40-HF-B-D-VIR, SM-20HF-B-D-KM, SM-32-HF-B-D-KM, SM-40HF-B-D-KM, and SM-50HF-B-D-KM are affected.
Check the unit's label for model numbers starting with SM-20HF-Batt through SM-50HF-B-D-KM. The units are labeled as 'Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1'.
No action is needed if your unit has a different model number or is not listed in the affected models.
We’ve drafted a message you can send SEDECAL to request your refund or repair — edit it as you like.
Subject: Recall Z-1754-2024 — SEDECAL SEDECAL Hello, I own a SEDECAL that is covered by recall Z-1754-2024 from SEDECAL. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.