Recall Z-0001-2018— Carl Zeiss Meditec AG
Class II · Terminated
Class II FDA medical device recall by Carl Zeiss Meditec AG, initiated 2017-08-30, terminated 2018-01-24. It names 5 FDA 510(k) clearances: K130549, K121653, K110590 and 2 more. 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..
- Recalling firm
- Carl Zeiss Meditec AG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-08-30
- Terminated
- 2018-01-24
- Firm location
- Oberkochen, N/A, Germany
510(k) clearances named in this recall
5 on FDA's record- K130549 — INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR
- K121653 — INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS
- K110590 — INTRABEAM NEEDLE APPLICATOR
- K090584 — INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS
- K051055 — INTRABEAM SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
The device had an incorrect printed calibration value on the calibration certificate.
Data sourced from openFDA. This site is unofficial and independent of the FDA.