The Recall Desk
HighFDA (Devices)·Z-2138-2018·Announced 2018-06-20

Ion Beam 12C Medical Device Recall for Unauthorized Modification Safety Risks

Ion Beam Applications S.A. is recalling 12C medical devices because using non-IBA accessories or unauthorized modifications may pose a safety risk.

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 involves a risk-of-harm product where specific injuries or illnesses have not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Ion Beam Applications S.A. is initiating a recall of its 12C medical devices. The recall is being conducted to notify customers that the use of non-IBA accessories, third-party equipment, or unauthorized modifications to the device may pose a safety risk.

The affected units were delivered in the USA, Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden. Specific serial numbers associated with this recall include PAT.000, PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.110, PAT.111, PAT.112, PAT.113, PAT.114, PAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123, SAT.126, and SBF.101.

Customers should contact Ion Beam Applications S.A. for further instructions regarding the recall and to ensure the safety of their equipment.

The recalled product

Product
12C
Manufacturer
Ion Beam Applications S.A.
Category
Medical Device — Radiation Therapy
Hazard

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)

  • Code/Serial Numbers: PAT.000
  • PAT.003
  • PAT.006
  • PAT.107
  • PAT.108
  • PAT.109
  • PAT.110
  • PAT.111
  • PAT.112
  • PAT.113
  • PAT.114
  • PAT.115
  • SAT.116
  • SAT.117
  • SAT.119
  • SAT.120
  • SAT.122
  • SAT.123
  • SAT.126
  • SBF.101

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Ion Beam Applications S.A. 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 →

Related recalls

Same manufacturer · Ion Beam Applications S.A.

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Same hazard · unauthorized modification

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