David M. Smith
11-10-2008, 03:36 PM
Date Recall Initiated April 25, 2007
Date Posted July 03, 2007
Recall Number Z-0987-2007
Product HD11XE Diagnostic Ultrasound System
Code Information 71384, USN0671426, ......... USN0671382, USN0671383, USN06 (For a complete list of serial numbers go to http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=52082)
Recalling Firm/ Manufacturer Philips Medical Systems
22100 Bothell-Everett Hwy.
P.O. Box 3003
Bothell , Washington 98041-3003
For Addition Information Contact Sarah Baxter
425-487-7665
Reason For Recall Potential for erroneous measurements which may lead to incorrect diagnosis based upon the presence of an inaccurate, undetectable error in clinical measurement or calculation. If the user exits an imaging mode while Active Annotation is in use, the system can enter an undefined state where the image scale calibration may not match the scale of the on-screen measurements and graphics and possib
Action On 04/25/2007 firm sent letters dated 04/23/2007 to consignees informing them of the issue and that a new software release to correct the issue became available 04/19/2007. The firm's Field Service Representatives will contact consignees to install the new software at no charge to the consignee.
Quantity in Commerce 562 devices
Distribution Worldwide.
Date Posted July 03, 2007
Recall Number Z-0987-2007
Product HD11XE Diagnostic Ultrasound System
Code Information 71384, USN0671426, ......... USN0671382, USN0671383, USN06 (For a complete list of serial numbers go to http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=52082)
Recalling Firm/ Manufacturer Philips Medical Systems
22100 Bothell-Everett Hwy.
P.O. Box 3003
Bothell , Washington 98041-3003
For Addition Information Contact Sarah Baxter
425-487-7665
Reason For Recall Potential for erroneous measurements which may lead to incorrect diagnosis based upon the presence of an inaccurate, undetectable error in clinical measurement or calculation. If the user exits an imaging mode while Active Annotation is in use, the system can enter an undefined state where the image scale calibration may not match the scale of the on-screen measurements and graphics and possib
Action On 04/25/2007 firm sent letters dated 04/23/2007 to consignees informing them of the issue and that a new software release to correct the issue became available 04/19/2007. The firm's Field Service Representatives will contact consignees to install the new software at no charge to the consignee.
Quantity in Commerce 562 devices
Distribution Worldwide.