The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0001-2018·Announced 2017-10-11

Carl Zeiss INTRABEAM PRS 500 Radiation Therapy Devices Recalled for Calibration Error

Carl Zeiss Meditec AG is recalling nine INTRABEAM PRS 500 radiation therapy devices because they had incorrect printed calibration values on their certificates.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text identifies the issue as an incorrect printed calibration value on the certificate, which aligns with the rubric for moderate severity involving documentation or labeling issues without reported injuries.

Plain-English summary

Carl Zeiss Meditec AG is recalling nine units of the Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The INTRABEAM System is indicated for radiation therapy treatments. The recall was initiated because the devices had an incorrect printed calibration value on the calibration certificate.

The affected devices were distributed nationwide, including in Arizona, California, Connecticut, the District of Columbia, Florida, Georgia, Ohio, and Pennsylvania. The recall includes specific serial numbers for both the Intrabeam units and their associated ion chambers, which are listed in the agency's official recall documentation.

Healthcare facilities and users of these devices should stop using the affected units and contact Carl Zeiss Meditec AG for further instructions on how to resolve the calibration documentation issue.

The recalled product

Product
Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABEAM System is indicated for radiation therapy treatments
Manufacturer
Carl Zeiss Meditec AG
Category
Medical Device — Radiation Therapy
Hazard
Affected units
9

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 (18)

  • Intrabeam ser. #6402501246
  • Ion chamber ser. #SN001254
  • Intrabeam ser. #6402501241
  • Ion chamber ser. #SN001745
  • Intrabeam ser. #6402100932
  • Ion chamber ser. #SN001994
  • Intrabeam ser. #6402100958
  • Ion chamber ser. #SN002096
  • Intrabeam ser. #6402101042
  • Ion chamber ser. #SN002265
  • Intrabeam ser. #6402101029
  • Ion chamber ser. #SN002270
  • Intrabeam ser. #6402101034
  • Ion chamber ser. #SN002302
  • Intrabeam ser. #6402101105
  • Ion chamber ser. #SN002651
  • and Intrabeam ser. #6402101130
  • Ion chamber ser. #SN002684.

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

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