Carl Zeiss INTRABEAM PRS 500…

Date

Oct. 11, 2017

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): 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)

Status

Terminated

Filed by

Carl Zeiss Meditec AG

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

Reason

The device had an incorrect printed calibration value on the calibration certificate.

Distribution pattern

Nationwide Distribution including AZ, CA, CT, DC, FL, GA, OH, and PA.

Quantity

9 devices

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.

Recall started

Aug. 30, 2017

Device type

System, Therapeutic, X-Ray

Root cause (FDA)

Process control

What the company told customers

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 iort.meditec.US@zeiss.com with any additional questions. You may also contact me at 925-557-4151 or viet.nguyen@zeiss.com

Recall number

Z-0001-2018

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0001-2018. The agency record governs; check it and the company before acting.