The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1202-2023·Announced 2023-03-08

Phoenix mKDR Mobile Diagnostic X-ray System Recalled for Erratic Movements

SEDECAL SA is recalling 53 units of the Phoenix mKDR mobile diagnostic x-ray system following 3 incidents of erratic movements. Facilities using the affected equipment should discontinue use and contact the manufacturer.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: This is an FDA Class II recall involving a medical device with 3 documented incidents of erratic movement. No injuries, hospitalizations, or property damage are reported in the source. Per the severity rubric, this qualifies as 'High' because it represents a risk-of-harm product where injury has not yet been reported.

Plain-English summary

SEDECAL SA is recalling 53 units of the Phoenix mKDR, a mobile diagnostic x-ray system. The recall was initiated following 3 reported incidents involving erratic movements of the device.

The affected units were distributed in the United States, Argentina, and Panama. They can be identified by their UDI (Unique Device Identifier) and specific serial numbers provided by the FDA.

Facilities and practitioners using this equipment should check whether they have any of the affected serial numbers. Those with recalled units should discontinue use and contact the manufacturer for further instructions regarding repair or replacement options.

The recalled product

Product
Phoenix mKDR, digital mobile diagnostic x-ray system
Manufacturer
SEDECAL SA
Category
Medical Device — Diagnostic Imaging
Hazard
Affected units
53

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)

  • UDI/DI 08436046003002
  • Serial Numbers: PH00092
  • PH00093
  • PH00094
  • PH00095
  • PH00097
  • PH00098
  • PH00099
  • PH00100
  • PH00110
  • PH00111
  • PH00112
  • PH00113
  • PH00114
  • PH00115
  • PH00116
  • PH00117
  • PH00118
  • PH00135
  • PH00136

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by SEDECAL SA under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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