Carl Zeiss INTRABEAM PRS 500: Incorrect Calibration Value Recall
Carl Zeiss Meditec recalls specific INTRABEAM PRS 500 radiation therapy devices with incorrect calibration values on certificates. Affected units may not deliver accurate radiation doses.
Lower-risk recall
The device had an incorrect printed calibration value on the calibration certificate.
Contact the company
What happened, in plain English
Carl Zeiss Meditec is recalling specific models of the INTRABEAM PRS 500 radiation therapy devices due to incorrect calibration values on their certificates. This could lead to inaccurate radiation doses during treatment, potentially affecting patient safety. Read more at govinfonow.com/recall/73099-carl-zeiss-intrabeam-prs-500-incorrect-calibration-value-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/73099-carl-zeiss-intrabeam-prs-500-incorrect-calibration-value-recall · Updated September 19, 2026 · FDA enforcement record: FDA #Z-0001-2018
Cite this page
“Carl Zeiss INTRABEAM PRS 500: Incorrect Calibration Value Recall.” GovInfoNow, updated September 19, 2026. https://govinfonow.com/recall/73099-carl-zeiss-intrabeam-prs-500-incorrect-calibration-value-recall. Based on FDA recall #Z-0001-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0001-2018%22&limit=1).
Why it’s dangerous
The calibration certificate has an incorrect printed value, which could result in inaccurate radiation dose delivery during treatment. This might cause unintended effects on the patient's health if the radiation dose is not properly calibrated.
Who’s affected
Patients receiving radiation therapy using the recalled INTRABEAM PRS 500 devices. Medical professionals who use these devices for treatment are most at risk of administering incorrect radiation doses.
How to tell if you have this one
Check for the product serial number on the device label. The specific INTRABEAM PRS 500 units recalled have serial numbers listed in the notice, including the ion chamber serial numbers.
- Brand
Carl Zeiss Meditec- Category
Medical device
What to do — step by step
Check Device Serial Numbers
Review the device's serial number and ion chamber serial number to confirm if it matches the listed recalled units.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 7 states.
FDA distribution: “Nationwide Distribution including AZ, CA, CT, DC, FL, GA, OH, and PA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Ohio, Pennsylvania.
Recall timeline
FDA terminated this recall 5 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0001-2018 (August 30, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0001-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.