PlainRecordsFDA · Medical device recall
INTRABEAM Balloon Applicator Set… and 2 more products
- Date
- Nov. 28, 2012
- 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, Inc.
- Reason
- A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
- Distribution pattern
- Nationwide Distribution including IL and MD
3 products in this recall
INTRABEAM Balloon Applicator Set…
- Product
- INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments
- Quantity
- 36 tootal, all lots
- Codes and lots
- Part number 304534-7500-000; lot number 540958.
- Recall started
- Oct. 25, 2012
- Device type
- System, Therapeutic, X-Ray
- Root cause (FDA)
- Nonconforming Material/Component
- What the company told customers
- Carl Zeiss Meditec sent an Important Field Corrective Action letter dated October 25, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately return the affected product to Carl Zeiss Meditec, Inc. A Carl Zeiss Meditec representative will contact the customer to schedule a visit to support the removal of the affected product. For questions customers were instructed to call 925-580-5371 or by email at v.venturo@meditec.zeiss.com. For questions regarding this recall call 925-557-4616.
- Recall number
- Z-0404-2013
INTRABEAM Balloon Applicator Set…
- Product
- INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
- Quantity
- 36 total, all lots
- Codes and lots
- Part number 304534-7500-001; lot number 540959.
- Recall started
- Oct. 25, 2012
- Device type
- System, Therapeutic, X-Ray
- Root cause (FDA)
- Nonconforming Material/Component
- What the company told customers
- Carl Zeiss Meditec sent an Important Field Corrective Action letter dated October 25, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately return the affected product to Carl Zeiss Meditec, Inc. A Carl Zeiss Meditec representative will contact the customer to schedule a visit to support the removal of the affected product. For questions customers were instructed to call 925-580-5371 or by email at v.venturo@meditec.zeiss.com. For questions regarding this recall call 925-557-4616.
- Recall number
- Z-0405-2013
INTRABEAM Balloon Applicator Set…
- Product
- INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
- Quantity
- 36 total, all lots
- Codes and lots
- Part number 304534-7500-002; lot number 540960.
- Recall started
- Oct. 25, 2012
- Device type
- System, Therapeutic, X-Ray
- Root cause (FDA)
- Nonconforming Material/Component
- What the company told customers
- Carl Zeiss Meditec sent an Important Field Corrective Action letter dated October 25, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately return the affected product to Carl Zeiss Meditec, Inc. A Carl Zeiss Meditec representative will contact the customer to schedule a visit to support the removal of the affected product. For questions customers were instructed to call 925-580-5371 or by email at v.venturo@meditec.zeiss.com. For questions regarding this recall call 925-557-4616.
- Recall number
- Z-0406-2013
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0404-2013, Z-0405-2013, Z-0406-2013. The agency record governs; check it and the company before acting.