PlainRecordsFDA · Medical device recall
GE Stereotaxy Positioner… and 1 more product
- Date posted by the FDA
- Sept. 26, 2008
- Status
- Terminated
- Filed by
- GE Healthcare
- Reason
- GE Healthcare has recently become aware of x-ray emission beyond the edge of the detector primary barrier. This issue occurs when an exam is performed in a specific angulated view associated with use of the Stereotactic Positioner of your Senographe DS Acquisition system and could impact patient safety. If the Stereotactic Positioner is removed when the examination arm is at 33 degrees and, th
- Distribution pattern
- AL, CA, CO, FL, IL, KS, MA, ME, MN,MO, NC, NJ, NM, NY OK, SC, TN, TX, and WI.
2 products in this recall
GE Stereotaxy Positioner…
- Product
- GE Stereotaxy Positioner, model 2405544-2, for use with Senographe DS Full Field Mammography system, models 2383168, 2383168-2, 2383168-3, 2383168-3-1, 2383168-4-1. The expected use of the Senographe DS Stereotaxy is an optional accessory for the Senographe system for mammography examinations.
- Quantity
- 27
- Codes and lots
- model 2405544-2, serial numbers: 00000434834BU8, 00000434837BU1, 00000437358BU5, 00000437363BU5, 00000437366BU8, 00000437366BU8, 00000444593BU8, 00000444603BU5, 00000450276BU1, 00000450289BU4, 00000454195BU9, 00000454197BU5, 00000454200BU7, 00000454202BU3, 0000046417BU0, 00000464622BU0, 00000464628BU7, 00000484259BU7, 00000484270BU4, 00000484290BU2, 00000484297BU7, 0000048429BU4, 00000492966BU7, 00000492975BU8, 00000494921BU0, 00000500104BU5, and 00000500118BU5.
- Recall started
- July 1, 2008
- Device type
- System, X-Ray, Mammographic
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- A Product Safety Notification letter, dated March 3, 2008, was sent to affected customers. The letter provided information about the safety issue, identified affected product and stated that GE Healthcare will provide a software upgrade. Contact GE Healthcare at 1-262-544-3894 for assistance.
- Recall number
- Z-2146-2008
GE Stereotaxy Positioner…
- Product
- GE Stereotaxy Positioner, model 2405544-3, for use with Senographe DS Full Field Mammography system, models 2383168, 2383168-2, 2383168-3, 2383168-3-1, 2383168-4-1. The expected use of the Senographe DS Stereotaxy is an optional accessory for the Senographe system for mammography examinations.
- Quantity
- 12
- Codes and lots
- model 2405544-3, Serial numbers: 00000509762BU1, 00000509764BU7, 00000543767BU8, 00000546136BU3, 00000546140BU5, 00000546772BU5, 00000546793BU1, 00000546794BU9, 00000546799BU8, 00000550251BU3, 00000550265BU3, and 00000550266BU1.
- Recall started
- July 1, 2008
- Device type
- System, X-Ray, Mammographic
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- A Product Safety Notification letter, dated March 3, 2008, was sent to affected customers. The letter provided information about the safety issue, identified affected product and stated that GE Healthcare will provide a software upgrade. Contact GE Healthcare at 1-262-544-3894 for assistance.
- Recall number
- Z-2147-2008
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-2146-2008, Z-2147-2008. The agency record governs; check it and the company before acting.