Proteus ONE and Proteus Plus
Reported: June 20, 2018 Initiated: September 16, 2016 #Z-2139-2018
Product Description
Proteus ONE and Proteus Plus
Reason for Recall
IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or third party equipment or unauthorized modifications to an IBA medical device may pose a safety risk.
Details
- Recalling Firm
- Ion Beam Applications S.A.
- Units Affected
- N/A
- Distribution
- Units were delivered in the USA, Korea, Germany, France, Czech Republic, Italy, Poland and Sweden.
- Location
- Louvain La Neuve, N/A
Frequently Asked Questions
What product was recalled? ▼
Proteus ONE and Proteus Plus. Recalled by Ion Beam Applications S.A.. Units affected: N/A.
Why was this product recalled? ▼
IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or third party equipment or unauthorized modifications to an IBA medical device may pose a safety risk.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 20, 2018. Severity: Moderate. Recall number: Z-2139-2018.
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