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

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

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