USA Instruments Incorporated

The following Serial Numbers of this device were subject to recall: 101, 102, 201, 202, 203, 204, 205, 206, 207, 309, 310.

Radiology Devices

2

No

Worldwide, including USA, (states of CA, NJ, PA, MN, IA, MA, WI, WA, and FL) Switzerland, the United Kingdom, France, Canada and Finland.

3.0T HD Head Neck Spine Array, Model 2415545, for GE 3.0T Excite MR System.

The following Serial Numbers of this device were subject to recall: 101, 201, 202, 203, 204, 205, 206, 207, 208, 308, 309, 310, 311, 312, 313, 314, 315, 316, 317, 318, 319, 320, 321, 322, 323, 324, 325, 326, 327, 328, and 329.

Radiology Devices

2

No

Worldwide, including USA, (states of CA, NJ, PA, MN, IA, MA, WI, WA, and FL) Switzerland, the United Kingdom, France, Canada and Finland.

1.5T HD Head Neck Spine Array, Model 2416329, for GE 1.5T Excite MR System.

All lot codes

Radiology Devices

2

No

Worldwide, including USA, Canada, Mexico, Argentina, Australia, Austria, Bhutan, Brazil, Chile, China, Denmark, Finland, Germany, Great Britain, Greece, Guatemala, Honduras, Hong Kong, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Netherlands, New Zealand, Panama, Puerto Rico, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, and Turkey.

The recalled product is the Large grid biopsy plate, part #2414797. The biopsy plate is labeled in part: Large Grid Biopsy Plate, part 2414797, For Use with the Liberty 9000 8-Channel Breast Coil, USA Instruments, Inc., Aurora, OH, sterile. || The breast biopsy plate is used with OEM coils (coils manufactured for Philips and Hitachi by USA Instruments) during Magnetic Resonance breast biopsy procedures. The large grid biopsy plate is packaged and sold as a part of catalogue 2414798 and 2415277.

All lot codes

Radiology Devices

2

No

Worldwide, including USA, Canada, Mexico, Argentina, Australia, Austria, Bhutan, Brazil, Chile, China, Denmark, Finland, Germany, Great Britain, Greece, Guatemala, Honduras, Hong Kong, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Netherlands, New Zealand, Panama, Puerto Rico, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, and Turkey.

The recalled product is the Disposable biopsy plate, part #U1-150131. The biopsy plate is labeled in part: Disposable Biopsy Plate, part U1-150131, For Use with the Liberty 9000 8-Channel Breast Coil, USA Instruments, Inc., Aurora, OH, sterile. || The breast biopsy plate is used with GE coils and with OEM coils (coils manufactured for Philips and Hitachi by USA Instruments) during Magnetic Resonance breast biopsy procedures. The disposable biopsy plate for use with GE coils is packaged and sold as a part of catalogue U1-160051, U1-150190, U1-150131. The disposable biopsy plate for use with OEM coils is packaged and sold as part of catalogue U1-150226, U1-150190, U1-155068, U1-160016, U1-160052, U1-160085, U1-160166, U1-160175, 2412158, 2416938, 2417842, and U1-150131.

All lot codes.

Radiology Devices

2

No

Worldwide, including USA, Canada, Mexico, Argentina, Australia, Austria, Bhutan, Brazil, Chile, China, Denmark, Finland, Germany, Great Britain, Greece, Guatemala, Honduras, Hong Kong, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Netherlands, New Zealand, Panama, Puerto Rico, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, and Turkey.

The recalled product is the Lateral biopsy plate, part #2414346. The biopsy plate is labeled in part: Lateral Biopsy Plate, part 2414346, For Use with the Liberty 9000 8-Channel Breast Coil, USA Instruments, Inc., Aurora, OH, sterile. The breast biopsy plate is used with GE coils during Magnetic Resonance breast biopsy procedures. The lateral biopsy plate is packaged and sold as a part of catalogue E8800BG, M3087JG, G3087JH, M3335LA.