InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product Usage: Usage: The system is an aid to locate anatomical structures during...
Reason: Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. On October 11, 2006...
Z-1985-2012July 18, 2012Salt Lake City, UT
superDimension, Inc
Class IITerminated
superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters ...
Reason: superDimension, Inc., is conducting a recall of certain superDimension Systems operating Software Version 4.0 - 4.9. The affected systems are sold under the product code AAS00016-...
Z-2001-2012July 18, 2012Minneapolis, MN
Philips Medical Systems (Cleveland) Inc
Class IITerminated
IntelliSpace Portal software and Extended Brillance Workspace software Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical app...
Reason: The Intellispace Portal software and Extended Brillance Workspace software may have significantly different results in the colors and size of the affected area when the customer us...
Z-1987-2012July 18, 2012Cleveland, OH
Philips Healthcare Inc.
Class IITerminated
Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange. Philips Xcelera Connect R2.x is a generic interface and data mapping engine between a Hospital Information Sy...
Reason: Xcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatted reports interface
Z-1942-2012July 11, 2012Andover, MA
Medtronic Navigation, Inc.
Class IITerminated
Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm¿ Imaging System is a mobile x-ray system designed for 2D fluoroscopic an...
Reason: Software Version 3.1.1 does not meet navigational accuracy.
Z-1849-2012June 27, 2012Littleton, MA
Natus Medical Incorporated
Class IITerminated
Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE). The Cool-Cap is indicated for use in full term infants (more than 36 week gestational...
Reason: Olympic Cool-Cap Cooling Module's power supply failed during treatment. The power supply failure can happen without prior indication and results in the unavailability of the syste...
Z-1843-2012June 27, 2012Seattle, WA
Philips Healthcare Inc.
Class IITerminated
Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon Stationary Fluoroscopic system
Reason: With Digital Diagnost (DIDI) R 2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in the lower right corner of the image. When such an image is mirrored back in...
Z-1818-2012June 27, 2012Andover, MA
Spacelabs Healthcare, Llc
Class IITerminated
The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. Product Usage: The Holter Analyzer analyzes information c...
Reason: The firm received reports of the Pathfinder LS software crashing after editing a batch of Holter Analyzer records. The software will stop with an error message requiring a restart....
Z-1831-2012June 27, 2012Issaquah, WA
Baxter Healthcare Corporation
Class ITerminated
Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump -- Class 2 medical device -- SIGMA LLC, Medina, NY 14103 ...
Reason: Recall expansion; the infusion pumps have the potential to fail causing inaccurate flow conditions during use. These conditions range from back flow to free flow, which could resul...
Z-1490-2012June 20, 2012Medina, NY
Philips Medical Systems (Cleveland) Inc
Class IITerminated
The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angl...
Reason: Philips is issuing a software update (version 3.2.4) to the Brilliance iCT and iCT SP systems currently running software version 3.2.0, 3.2.1 or 3.2.3, addressing a number of non-c...