The Recall Desk
HighFDA (Devices)·Z-1084-2016·Announced 2016-03-16

Sedecal Mobile X-ray Systems Recalled for Uncommanded Movements

Sedecal S.A. is recalling 349 mobile X-ray systems because static electricity and other issues can cause uncommanded movements.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (uncommanded movement of a heavy medical device) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Sedecal S.A. is recalling 349 mobile wDR motorized portable diagnostic X-ray systems. These devices are intended for use by qualified doctors or technologists to take diagnostic radiographic images of adult and pediatric patients.

The recall is due to uncommanded movements of the motorized system. The manufacturer has observed that static electricity, along with previously noted encoder and gauge problems, can elicit this unwanted behavior. This recall is related to previous 806 Notifications regarding similar issues.

The affected units were distributed nationwide, including in AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, and WI. Users should check their serial numbers against the provided list and contact the manufacturer for further instructions.

The recalled product

Product
Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts
Manufacturer
Sedecal S.A.
Category
Medical Device — Diagnostic Imaging
Hazard
Affected units
349

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Serial Numbers: 485886/SN11000007
  • 485062/SN11000009
  • 488169/SN11000011
  • 485061/SN11000012
  • 485059/SN11000013
  • 485060/SN11000015
  • 489089/SN11000016
  • 489616/SN11000033
  • 490027/SN11000034
  • 489694/SN11000035
  • 489695/SN11000036
  • 489696/SN11000037
  • 490221/SN11000039
  • 489088/SN11000040
  • 493566/SN11000047
  • 493565/SN11000048
  • 494867/SN11000051
  • 494941/SN11000052
  • 492417/SN11000053
  • 494456/SN11000055

Distribution

Distributed nationwide across the United States.

The notice also names 40 states specifically:

Related recalls

Same manufacturer · Sedecal S.A.

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Same hazard · uncommanded movement

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