Z-0001-2018Class II

Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG...

Name: Z-0001-2018 Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG...
Creator: Carl Zeiss Meditec AG
Published: 2017-08-30
License: https://open.fda.gov/license/

Carl Zeiss Meditec Inc / initiated 2017-08-30 / Terminated / root cause: manufacturing process

FDA source

Carl Zeiss Meditec AG began a recall of 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... on 2017-08-30. FDA classified it as Class II and gives the reason as "The device had an incorrect printed calibration value on the calibration certificate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0001-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-30
Posted: 2017-10-02
Terminated: 2018-01-24
Recalling firm: Carl Zeiss Meditec Inc
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
Product code: JAD System, Therapeutic, X-Ray
Reason for recall: The device had an incorrect printed calibration value on the calibration certificate.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Zeiss sent a Field Safety Corrective Action letter dated August 30. 2017, to all affected customers via FedEx. Recall letters were issued by the U.S. Agent on behalf of the /recalling firm on 8/30/2017 via FedEx. Customers were given the following instructions: 1. A member of the ZEISS service staff will contact you to coordinate the steps to be taken and to schedule the update of your system. Alternatively, you may update the system yourself by following the attached instructions. In case you update the system yourself, a ZEISS service staff member will still be visiting your site to confirm the updated calibration. 2. Please complete and return the attached response form to acknowledge receipt of this notification. If you have question regarding this field safety corrective action, you can contact your ZEISS customer service at 800-442-4020 or by email at [email protected] with any additional questions. You may also contact me at 925-557-4151 or [email protected]
Quantity in commerce: 9 devices
Distribution: Nationwide Distribution including AZ, CA, CT, DC, FL, GA, OH, and PA.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0001-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0001-2018	Class II	Terminated	Voluntary: Firm initiated	2017-10-11	2017-10-02

Product code JAD

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)