Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP
Reason: An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in error that may impact patient safety if used on patients.
Z-0832-2022April 6, 2022Natick, MA
Siemens Medical Solutions USA, Inc
Class IIOngoing
Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system
Reason: Siemens Healthineers has identified a software error in previous software version VB10 for the Ysio fully automated system. The unit may process incorrect internal values for the p...
Z-0841-2022April 6, 2022Malvern, PA
Philips Healthcare
Class IICompleted
Azurion systems with software release R2.0.x
Reason: In the Azurion system, the user can add a new study to a patient by selecting the option "Add Study". The Add Study dialogue box is then displayed where the Patient Type is select...
Z-0734-2022March 30, 2022Andover, MA
Abbott Laboratories, Inc
Class IIOngoing
Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fu...
Reason: Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe...
Z-0749-2022March 23, 2022Irving, TX
Stryker Corporation
Class IIOngoing
1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope/s...
Reason: A software defect in the camera control unit (CCU) will cause the image on the monitor to flip upside-down into an incorrect orientation. The potential of harms are conversion to o...
Z-0728-2022March 16, 2022San Jose, CA
RAYSEARCH LABORATORIES AB
Class IIOngoing
RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.61 , 8.0.1.10 , ...
Reason: If a new primary image set is selected while the cine loop is running, the primary image set will be displayed as both primary and secondary image set in all side-by-side views. Th...
Z-0732-2022March 16, 2022Stockholm, N/A
Brainlab AG
Class IIOngoing
ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20...
Reason: The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
Z-0733-2022March 16, 2022Munich, N/A
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Class IITerminated
IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software
Reason: Tile kits that allow one to install and situate a video camera within a patient environment are not fitting properly in some domestic institution ceiling tile grids that have a thi...
Z-0661-2022March 2, 2022Oakville
Philips North America Llc
Class IITerminated
eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2, eCareManager version 4.6.0- a software tool intended for us...
Reason: eCareManager (eCM) Sentry Score software not approved for use
Z-0549-2022February 9, 2022Cambridge, MA
Siemens Medical Solutions USA, Inc.
Class IIOngoing
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
Reason: Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace circumference value is overestimated and may potentially result in misdiagnosis of...
Z-0547-2022February 9, 2022Issaquah, WA
Siemens Medical Solutions USA, Inc
Class IITerminated
Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
Reason: Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray poss...
Z-0517-2022February 2, 2022Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
Reason: Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray poss...
Z-0516-2022February 2, 2022Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
Reason: Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray poss...
Z-0515-2022February 2, 2022Malvern, PA
Biomerieux Inc
Class IITerminated
API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. It uses miniaturized tests as well as a specially adapted databa...
Reason: Risk of misidentification or delayed results with the absence of identification due to thermoforming defect.
Z-0525-2022February 2, 2022Hazelwood, MO
Siemens Medical Solutions USA, Inc
Class IIOngoing
1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 The Sensis ...
Reason: Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software version VD12A, which could cause possible hazard to patients, operators, or other ...
Z-0499-2022January 26, 2022Malvern, PA
Konica Minolta Healthcare Americas, Inc.
Class IITerminated
ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for medical diagnostics Product number: ADFR and ADJC
Reason: lmagePilot versions 1.92 and 1.93 paired with an AeroDR or Momentum Panel potential risk of incorrect length measurement/area calculation if incorrect power sequence is followed
Z-0500-2022January 26, 2022Wayne, NJ
PTW NORTH AMERICA CORPORATION
Class IITerminated
Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
Reason: When a measurement with a PTW detector array is performed with the software BeamAdjust 2.2 or VeriSoft 8.0, a measurement error can occur under specific conditions. This error can ...
Reason: Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off
Z-0477-2022January 19, 2022Mason, OH
Siemens Medical Solutions USA, Inc
Class IIOngoing
SOMATOM Edge Plus-Computed tomography system Model 1026700
Reason: Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
Z-0474-2022January 19, 2022Malvern, PA
Siemens Medical Solutions USA, Inc
Class IIOngoing
SOMATOM Definition Edge -Computed tomography system Model 10590000
Reason: Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
Z-0475-2022January 19, 2022Malvern, PA
Ion Beam Applications S.A.
Class IITerminated
Proteus 235; Version: PTS-8 versions before PTS-8.7.2
Reason: Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) while some processes are still running in the test environment (tcs user). Initiati...
Z-0466-2022January 19, 2022Louvain-la-neuve, N/A
Abbott Molecular, Inc.
Class IIOngoing
Alinity m System, Part No. 08N53-002
Reason: There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.