SEDECAL SA recall records

53 reported ongoing

53 records in this archive. Latest source date Jun 10, 2025.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

SED URS LP, Mobile X-ray system

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Class IIReported ongoing

Distribution: US: CA, IL, and NJ

Official source for SED URS LP, Mobile X-ray system
FDA device enforcement

Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF-Batt; c. SM-40HF-Batt; d. SM-50HF-Batt; e. SM-40-HF-B-D-VIR; f...

Potential interference with the anti-fall system.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide in the states of CA, IL, NJ, and areas yet to be identified by Philips Medical Systems DMC GmbH, Hamburg, Germany.

Official source for Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF...
FDA device enforcement

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, sitt...

Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.

Class IIReported ongoing

Distribution: Distribution was made to AL, FL, and NC. There was no military/government distribution.

Official source for Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a uni...
FDA device enforcement

Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500

Due to un-commanded movement of mobile x-ray unit.

Class IIReported ongoing

Distribution: U.S.: KY, WI, FL, DE, WV, CA, MO, NY, NC, AL, AR, MS, GA, IL, IA, TN, KS, KY, IN, HI, OH, WY, PA, NV, RI, UT, AZ, OK, MN, ME, MT, WA, VA, SD, MI, LA, and TX O.U.S.: N/A

Official source for Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500
FDA device enforcement

MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007

While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine positioning control button. This would result in ...

Class IIReported ongoing

Distribution: US Nationwide distribution. There was government distribution but no military distribution.

Official source for MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007

Reasons in these listed records

  • Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
  • Potential interference with the anti-fall system.
  • Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
  • There is a software login in issue that may prevent the user from logging in.

These examples come from this result page and are not a ranking of every recall reason.

Checking SEDECAL SA

Is there a recall on sedecal sa right now?

This archive contains 53 records, including 53 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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