Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Numb...
Reason: (1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for Open Channel Assays reverting to Default Value would shift test results by the magni...
Z-0449-2022January 12, 2022Tarrytown, NY
Abbott Molecular, Inc.
Class IIOngoing
Alinity m System, Part No. 08N53-002
Reason: There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.
Z-0462-2022January 12, 2022Des Plaines, IL
Intuitive Surgical, Inc.
Class IIOngoing
da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605 ASSY,SSC,SP1098,P4/ 380940-44 / 00886874114735 ASSY,VSS,SP1098,P4/ 380941...
Reason: Issue was identified during internal engineering evaluation. Use of the system with the affected software version may experience either an inability to deliver energy or an inadver...
Z-0419-2022January 5, 2022Sunnyvale, CA
Philips North America Llc
Class IITerminated
Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally inva...
Reason: Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mounted on the Monitor Ceiling Suspension (MCS) can come loose, the Extra monitors might...
Z-0416-2022December 29, 2021Cambridge, MA
Medtronic Navigation, Inc.
Class IOngoing
Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial, Model: 9733763, and StealthStation Cranial, Model: 9735585
Reason: Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer synchronized with the rest of the navigational information on the screen and may displ...
Z-0383-2022December 29, 2021Louisville, CO
Philips North America Llc
Class IIOngoing
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
Reason: Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detecto...
Z-0356-2022December 15, 2021Cambridge, MA
Philips North America Llc
Class IIOngoing
Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
Reason: Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detecto...
Z-0357-2022December 15, 2021Cambridge, MA
Philips North America Llc
Class IIOngoing
BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075
Reason: Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detecto...
Z-0355-2022December 15, 2021Cambridge, MA
Orchestrate Orthodontic Technologies, Inc.
Class IITerminated
O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth movement) MKT-LB-002 Rev 1 for Orchestrate3d Software v.3.1 - v5.0.4
Reason: Due to product label/labeling being altered from it's approved state.
Z-0334-2022December 15, 2021Rialto, CA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Drive with software syngo.CT VB20 Model #10431700
Reason: software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay i...
Z-0287-2022December 1, 2021Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Definition AS with software syngo.CT VB20 Model #8098027
Reason: software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay i...
Z-0284-2022December 1, 2021Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603
Reason: software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay i...
Z-0286-2022December 1, 2021Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Force with software syngo.CT VB20 Model #10742326
Reason: software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay i...
Z-0283-2022December 1, 2021Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
Reason: software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay i...
Z-0285-2022December 1, 2021Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094141
Reason: If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may...
Z-0299-2022December 1, 2021Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848280
Reason: If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may...
Z-0300-2022December 1, 2021Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
Artis Q.zen floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848353
Reason: If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may...
Z-0303-2022December 1, 2021Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Confidence with software syngo.CT VB20 Model #10590100
Reason: software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay i...
Z-0288-2022December 1, 2021Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
Artis zee multi-purpose with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094139
Reason: If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may...
Z-0298-2022December 1, 2021Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10848355
Reason: If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may...
Z-0305-2022December 1, 2021Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848282
Reason: If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may...
Reason: Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, loss of module communic...
Z-0272-2022December 1, 2021Irving, TX
Siemens Medical Solutions USA, Inc
Class IITerminated
Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094135
Reason: If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may...
Z-0296-2022December 1, 2021Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848281
Reason: If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may...
Z-0301-2022December 1, 2021Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848354
Reason: If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may...