Z-1675-2013Class II

AngioDynamics RITA Main Cable, 9 Pin to 14 Pin, REF 700-101892. RITA Main Cables are indicated for use with...

Name: Z-1675-2013 AngioDynamics RITA Main Cable, 9 Pin to 14 Pin, REF 700-101892. RITA Main Cables are indicated for use with...
Creator: Angiodynamics, INC
Published: 2013-06-11
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2013-06-11 / Terminated / root cause: packaging

FDA source

Angiodynamics, INC began a recall of AngioDynamics RITA Main Cable, 9 Pin to 14 Pin, REF 700-101892. RITA Main Cables are indicated for use with the RITA RF Generators and RITA electrosurgical... on 2013-06-11. FDA classified it as Class II and gives the reason as "The RITA Main Cable product contains the incorrect Instructions for Use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1675-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-11
Posted: 2013-07-10
Terminated: 2015-06-12
Recalling firm: Boston Scientific Corporation
Product: AngioDynamics RITA Main Cable, 9 Pin to 14 Pin, REF 700-101892. RITA Main Cables are indicated for use with the RITA RF Generators and RITA electrosurgical devices.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: The RITA Main Cable product contains the incorrect Instructions for Use.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Consignees were notified via certified mail on 06/11/2013 with an "Urgent Medical Device Field Safety Correction" notification. This included the correct Instructions for Use and the recommended actions.
Quantity in commerce: 13 units
Distribution: Worldwide Distribution, including the US, Austria, China, Italy, Russia and the UK.
Product codes and lots: Catalog #700-101892, Lot number: 30.12

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1675-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1675-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-10

Product code GEI

K040989Class IIRita SystemsRita Medical Systems / cleared 2004-04-28

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)