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  Radiology Recalls

March 24, 2011

PRODUCT - CT

 

Brilliance 64 S/N 9089, 9551, 9548.

The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Code Information
Model #728231, S/N 9089, 9551, 9548.

Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland, Ohio 44143-2131

Reason for Recall
During the version 2.6 software upgrade, the system was not recalibrated with the infant phantom for the infant protocol.

Philips sent an URGENT - Medical Device Correction letter dated January 31, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers may consider reviewing any infant images that may have been affected during the Field Test to confirm reading accuracy. For further information or support concerning this issue, customers could contact their local Philips representative or local Philips Healthcare office for North America and Canada contact the Customer Care Solutions Center (1-800-722-9377 begin_of_the_skype_highlighting 1-800-722-9377 end_of_the_skype_highlighting, option 5: Enter Site ID or follow the prompts).
Quantity in Commerce
3
Distribution
Worldwide Distribution - USA including CO, IN, and TN and the countries of Norway, Israel, and Germany

March 10, 2011

PRODUCT - CT

 

BrightSpeed Excel/Edge/Elite Select Computed Tomography X-Ray System. For head, whole body X-ray Computed Tomography applications. Gantry model numbers 5191001, 5191002, 5191003, and 5191003-2. Recall # Z-0286-2011
CODE
None
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI, by letter on May 1, 2010. Firm initiated recall is ongoing.
REASON
Failure to properly document the CTDI in the Technical Reference or User Manual.
VOLUME OF PRODUCT IN COMMERCE
103 units
DISTRIBUTION
Nationwide

January 20, 2011

PRODUCT - CT

 

HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects. Recall # Z-0007-2011
CODE
Serial Numbers: 074639HM6, 659297YM6, 695155YM2, 730392YM8, 777756YM8, 789223YM5, 818161YM2, 836965YM4, 836971YM2, 864568YM 1, 869641 YM 1, 530941YM4, 594144YM8, 659292YM7, 678189YM2, 65931 1YM5, 696890YM3, 530873YM9, 659208YM3, 730349YM8, 544504YM4, 766560YM7, 766630YM8, 856398YM3, 474793YM7, 530946YM3, 874664YM6, 813279YM7, 839995YM8, 854095YM7, 869512YM4, 766587YMO, 887561YM9, 840000YM4, 813261 YM5, 717723YM1, 717727YM2, 877979YM5, 808479YMO, 812782YM1, 659200YMO, 766610OYMO, 877971YM2, 730393YM6, and 865531YM8
RECALLING FIRM/MANUFACTURER
GE Medical Systems, LLC, Waukesha, WI, by letter and visit beginning September May 1, 2009. Firm initiated recall is ongoing.
REASON
It was discovered that the operator console did not have a label affixed in accordance with 21CFR 1010.2 indicating certification to applicable performance standards.  
VOLUME OF PRODUCT IN COMMERCE
45 units (13 Nationwide)
DISTRIBUTION
ME, FL, IA, AL, CT, CA, TX, KS, KY, OH, WV and countries of Japan, Russian Federation, India, Argentina, Brazil, Italy, Poland, Puerto Rico, Romania, and Saudi Arabia

 

PRODUCT
1) HiSpeed LXI (2200997).  Recall # Z-0744-2011; 
2) HiSpeed LX/l (2200997-2). Recall # Z-0745-2011;
3) HiSpeed DX/I (2201000). Z-0746-2011;
4) HiSpeed DX/I (2201000-2). Recall # Z-0747-2011;
5) HiSpeed DX/I (2249696). Recall # Z-0768-2011;
6) HiSpeed DX/I (2249696-2). Recall # Z-0770-2011;
7) HiSpeed FX/I (2200997 with Gantry mo. #2200997). Recall # Z-0771-2011;  
8) HiSpeed FX/I (2200997 with Gantry mo. #2201000). Recall # Z-0772-2011;
9) HiSpeed FX/I (2200997 with Gantry mo. #2200997-2). Recall # Z-0773-2011;
10) HiSpeed FX/I (2200997 with Gantry mo. #2201000-2). Recall # Z-0774-2011;
11) HiSpeed FX/I (2200997 with Gantry mo. #2249696). Recall # Z-0775-2011;  
12) HiSpeed FX/I (2200997 with Gantry mo. #2249696-2). Recall # Z-0776-2011; 
13) HiSpeed FX/I (2200997-2 with Gantry mo. #2200997). Recall # Z-0777-2011;   
14) HiSpeed FX/I (2200997-2 with Gantry mo. #2200997-2). Recall # Z-0778-2011;
15) HiSpeed FX/I (2200997-2 with Gantry mo. #2201000). Recall # Z-0779-2011;
16) HiSpeed FX/I (2200997-2 with Gantry mo. #2201000-2). Recall # Z-0780-2011;
17) HiSpeed FX/I (2200997-2 with Gantry mo. #2249696). Recall # Z-0781-2011;
18) HiSpeed FX/I (2200997-2 with Gantry mo. #2249696-2). Recall # Z-0782-2011;
19) HiSpeed FX/I (2201000-2 with Gantry mo. #2200997). Recall # Z-0783-2011;
20) HiSpeed FX/I (2201000-2 with Gantry mo. #2200997-2). Recall # Z-0784-2011;
21) HiSpeed FX/I (2201000-2 with Gantry mo. #2201000). Recall # Z-0785-2011;
22) HiSpeed FX/I (2201000-2 with Gantry mo. #2201000-2).  Recall # Z-0786-2011;
23) HiSpeed FX/I (2201000-2 with Gantry mo. #2249696). Recall # Z-0787-2011;
24) HiSpeed FX/I (2201000-2 with Gantry mo. #2249696-2). Recall # Z-0788-2011
CODE
With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI, by letter on February 1, 2010. Firm initiated recall is ongoing.
REASON
A defect with the hardware and software displaying the incorrect dose data. 
VOLUME OF PRODUCT IN COMMERCE
102 units
DISTRIBUTION
Nationwide


June 10, 2010 PRODUCT - Mammography
GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis. Recall # Z-1747-2010
CODE
Serial Numbers: 000000A9316002 000000A9316008 000000F9314002 000000F9314013 000000Q9309007 000000Q9309012 000000Q9309013 000000Q9309015 000000W9321002 000000W9321004 000000A9316004 000000A9316014 000000A9316015 000000A9345002 000000A9345003 000000A9345007 000000A9345009 000000A9345019 000000A9345020 000000F9314005 000000F9314010 000000F9314014 000000Q9309002 000000Q9309003 000000Q9309006 000000W9321003 000000P9300003 000000A9316012 000000P9300002 000000F9314011 000000W9321001 000000W9321007 000000W9321008 000000W9321010 000000W9321006 000000A9316006 000000A9316003 000000A9316005 000000P9300001 000000Q9309010 000000Q9309014 000000A9345015 000000Q9309005 000000A9316011 000000A9345012 000000A9345013 000000A9345014 000000A9345016 000000A9345018 000000F9314004 000000Q9309001 00000D10011003 00000D10011006 000000A9316001 000000F9314008 000000F9314012 000000P9300004 000000W9321009 000000A9316010 000000F9314007 000000W9321005 000000A9316007 000000A9316009 000000F9314015 000000F9314006 000000Q9356005 00000ZA9260001 000000Q9309008 000000A9345001 000000A9345017 000000F9314001 000000Q9309004 000000Q9356001
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by letter dated February 8, 2010.
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
REASON
GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. When using the Print Image or Print Screen feature on SenoAdvantage 2.2, the Scale factor annotation printed on hard copy images is inaccurate. Secondary Capture (SCPT) images displayed on the screen and Secondary Capture hard copy images may also contain the inaccurate Scale factor annotation. This issue may result in a potential miscalculation of size.
VOLUME OF PRODUCT IN COMMERCE
73 devices
DISTRIBUTION
CA, FL, GA, MD, NJ, NM, NY, NC, OK, TX. and Internationally

 

 

 

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