The Recall Desk
HighFDA (Devices)·Z-2322-2012·Announced 2012-09-12

Siemens Recalls Mobilett Mira Mobile X-Ray Systems Due to Switch Defect

Siemens is recalling 20 Mobilett Mira mobile X-ray systems because a switch may become trapped, causing the unit to move continuously.

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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (uncontrolled movement of heavy medical equipment) where injury has not yet been reported.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 20 units of the Mobilett Mira Mobile X-Ray System. The recall was initiated after the manufacturer identified a potential issue during regular product monitoring.

The defect involves the switch on the motor drive handle, which may become loose and slide horizontally to the right, becoming trapped under the cover. This malfunction can cause the X-ray system to move continuously during normal clinical operation.

The affected units were distributed nationwide, including in Georgia, Idaho, Illinois, Iowa, Kansas, North Carolina, Ohio, South Dakota, Texas, and Wisconsin. The specific units are identified by Model number 10273100 and serial numbers 1034, 1038, 1041, 1042, 1043, 1053, 1057, 1070, 1079, 1081, 1088, 1098, 1099, 1102, 1103, 1105, 1106, 1107, 1108, and 1112. Siemens has issued Update Instruction XP038/12/S to address the issue.

The recalled product

Product
Siemens Mobilett Mira. Mobile X-Ray System.
Affected units
20

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)

  • Model number 10273100 -- serial numbers 1034
  • 1038
  • 1041
  • 1042
  • 1043
  • 1053
  • 1057
  • 1070
  • 1079
  • 1081
  • 1088
  • 1098
  • 1099
  • 1102
  • 1103
  • 1105
  • 1106
  • 1107
  • 1108
  • and 1112.

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Same manufacturer · Siemens Medical Solutions USA, Inc

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