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Rita Medical Systems, Inc.

Also registered as Rita Medical Systems

United StatesFDA applicant, unverified

Devices
20
FDA recalls
9

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

Catalogue20

Newest first, rows 1-20 of 20

Search and filter all 20 devices
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Rows 1-20 of 20

FDA recalls9

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

  • 2007

    • 3 Oct 2007 Z-0149-2008 Unclassified (pre-2012) Terminated Incorrect Size Catheter: The product may contain an incorrect size catheter. Distribution: Worldwide : USA including states of AL, AR, CA, CO, FL, GA, MD, NC, OH, TX, and VT, and countries of Australia, Korea…
      Full distribution text Worldwide : USA including states of AL, AR, CA, CO, FL, GA, MD, NC, OH, TX, and VT, and countries of Australia, Korea and The Netherlands.
      Submission number: K010189
    • 3 Apr 2007 Z-0752-2007 Unclassified (pre-2012) Terminated The product may have a cracked tray which can compromise the sterility of the product. Distribution: Worldwide, including USA, Austria, Canada, Croatia, Denmark, Egypt, Estonia, France, Finland, Germany, Greece, Hong…
      Full distribution text Worldwide, including USA, Austria, Canada, Croatia, Denmark, Egypt, Estonia, France, Finland, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Latvia, Netherlands, Norway, Poland, Republic of Ireland, Romania, Russia, Saudi Arabia, Singapore, Solomon Islands, South Africa, Spain, Switzerland, UK, and United Arab Emirates.
      Submission number: K992693
    • 3 Apr 2007 Z-0753-2007 Unclassified (pre-2012) Terminated The product may have a cracked tray which can compromise the sterility of the product. Distribution: Worldwide, including USA, Austria, Canada, Croatia, Denmark, Egypt, Estonia, France, Finland, Germany, Greece, Hong…
      Full distribution text Worldwide, including USA, Austria, Canada, Croatia, Denmark, Egypt, Estonia, France, Finland, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Latvia, Netherlands, Norway, Poland, Republic of Ireland, Romania, Russia, Saudi Arabia, Singapore, Solomon Islands, South Africa, Spain, Switzerland, UK, and United Arab Emirates.
      Submission number: K983871
    • 3 Apr 2007 Z-0754-2007 Unclassified (pre-2012) Terminated The product may have a cracked tray which can compromise the sterility of the product. Distribution: Worldwide, including USA, Austria, Canada, Croatia, Denmark, Egypt, Estonia, France, Finland, Germany, Greece, Hong…
      Full distribution text Worldwide, including USA, Austria, Canada, Croatia, Denmark, Egypt, Estonia, France, Finland, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Latvia, Netherlands, Norway, Poland, Republic of Ireland, Romania, Russia, Saudi Arabia, Singapore, Solomon Islands, South Africa, Spain, Switzerland, UK, and United Arab Emirates.
      Submission number: K992693

  • 2006

    • 2 May 2006 Z-0887-06 Unclassified (pre-2012) Terminated Misbranding; Product may have the wrong device handle which incorrectly identifies the product and also has incorrect deployment depth marker. Distribution: AL, AR, FL, LA, MA, NJ, NY, PA, TN, TX, UT and Italy Submission number: K010060
    • 2 May 2006 Z-0888-06 Unclassified (pre-2012) Terminated Misbranding; Product may have the wrong device handle which incorrectly identifies the product and also has incorrect deployment depth marker Distribution: AL, AR, FL, LA, MA, NJ, NY, PA, TN, TX, UT and Italy Submission number: K010060

  • 2005

    • 21 Sep 2005 Z-0031-06 Unclassified (pre-2012) Terminated Devices for which sterility may be compromised as evidenced by a loss of package integrity. Distribution: Product was released for distribution to 63 consignees nationwide. The recall was appropriately extended to the…
      Full distribution text Product was released for distribution to 63 consignees nationwide. The recall was appropriately extended to the consumer/user level; i.e., the physicians and hospitals who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
      Submission number: K051420

  • 2004

    • 16 Jun 2004 Z-1076-04 Unclassified (pre-2012) Terminated Inaccurate temperature readings may be displayed by the device, actual temperature could be 2.5-3 degrees C higher than displayed. Distribution: Product was shipped to 18 field representatives and 87 customers (hospitals and medical centers

  • 2003

    • 6 Oct 2003 Z-0087-04 Unclassified (pre-2012) Terminated The product displays inaccurate temperature readings, patient skin burns can occur before getting to higher temperature reading. Distribution: Product was released for distribution to 66 consignees in US. The product received nationwide distribution. The recall…
      Full distribution text Product was released for distribution to 66 consignees in US. The product received nationwide distribution. The recall was appropriately extended to the user level; i.e., the hospitals that received the recalled product. There were no shipments to foreign or Canadian distribution, however, it includes one military distribution: Wilford Hall Medical Center, 2200 Berquist Dr., 31, Lackland AFB, TX 78236.
      Submission number: K031926

Frequently asked questions

How many devices does Rita Medical Systems, Inc. have in the registry?

The registry currently lists 20 devices for Rita Medical Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Rita Medical Systems, Inc.'s devices?

Among its 20 most recently registered devices, Rita Medical Systems, Inc. has devices listed in FDA 510(k) (20 devices).

What risk classes do Rita Medical Systems, Inc.'s devices fall under?

Among its 20 most recently registered devices, the classes recorded for Rita Medical Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Rita Medical Systems, Inc.?

FDA recall records list 9 recalls initiated by Rita Medical Systems, Inc., the most recent initiated on 3 Oct 2007. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Rita Medical Systems, Inc. in the registry?

The most recently registered devices listed for Rita Medical Systems, Inc. include VORTEX EZ VASCULAR ACCESS PORT, OMNIPICC PI, RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES and RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR.

Generated automatically from registry data and not verified by a human reviewer.