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U.S. Department of Health and Human Services

Class 2 Device Recall Carl Zeiss INTRABEAM PRS 500

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 Class 2 Device Recall Carl Zeiss INTRABEAM PRS 500see related information
Date Initiated by FirmAugust 30, 2017
Create DateOctober 02, 2017
Recall Status1 Terminated 3 on January 24, 2018
Recall NumberZ-0001-2018
Recall Event ID 78082
510(K)NumberK051055 K090584 K110590 K121653 K130549 
Product Classification System, therapeutic, x-ray - Product Code JAD
ProductCarl 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
Code Information 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.
Recalling Firm/
Manufacturer		 Carl Zeiss Meditec AG
Rudolf-Eber-Str. 11
Oberkochen Germany
Manufacturer Reason
for Recall		The device had an incorrect printed calibration value on the calibration certificate.
FDA Determined
Cause 2		Process control
ActionZeiss 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 iort.meditec.US@zeiss.com with any additional questions. You may also contact me at 925-557-4151 or viet.nguyen@zeiss.com
Quantity in Commerce9 devices
DistributionNationwide Distribution including AZ, CA, CT, DC, FL, GA, OH, and PA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JAD
510(K)s with Product Code = JAD
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