Reason: When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorr...
Reason: When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorr...
Z-2581-2021October 6, 2021Shirley, NY
WOM World of Medicine AG
Class IIOngoing
Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
Reason: When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system control unit display will freeze because the internal software calculation threshold i...
Reason: Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.
Z-2483-2021September 29, 2021Bothell, WA
Siemens Medical Solutions USA, Inc
Class IIOngoing
Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems: SOMATOM go.Up - Model 11061620 SOMATOM go.Up - Model 11...
Reason: Software versions may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Sporadic software errors may also occur during interve...
Reason: Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software
Z-2517-2021September 29, 2021Tel Aviv-Yafo
Roche Diagnostics Operations, Inc.
Class IITerminated
cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
Reason: Under specific circumstances created by the user, the cobas e flow test results could be replaced by an automatic result sent to the lab LIS. This automatic result could be release...
Z-2444-2021September 22, 2021Indianapolis, IN
Abbott Laboratories
Class IIOngoing
Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model number LN 03R70-01
Reason: Due to potential performance issues with software version 3.2.3 and earlier. Performance issues are: 1) There is the potential for onboard reagents past their lot expiration date...
Z-2472-2021September 22, 2021Irving, TX
Angiodynamics, Inc.
Class IITerminated
Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US
Reason: Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up.
Reason: Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up.
Reason: Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up.
Reason: Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up.
Z-2438-2021September 15, 2021Queensbury, NY
Siemens Medical Solutions USA, Inc
Class IITerminated
Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10...
Reason: Due to a software error, the IAS (Image Acquisition System) may sporadically fail during startup/ restart, and result in delay of clinical treatment
Z-2404-2021September 8, 2021Malvern, PA
Elekta Inc
Class IIOngoing
Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
Reason: If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams...
Z-2406-2021September 8, 2021Saint Charles, MO
DePuy Orthopaedics, Inc.
Class IITerminated
TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component in...
Reason: Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, cau...
Z-2398-2021September 8, 2021Warsaw, IN
DePuy Orthopaedics, Inc.
Class IITerminated
TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component in...
Reason: Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, cau...
Z-2395-2021September 8, 2021Warsaw, IN
DePuy Orthopaedics, Inc.
Class IITerminated
TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component in...
Reason: Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, cau...
Z-2400-2021September 8, 2021Warsaw, IN
DePuy Orthopaedics, Inc.
Class IITerminated
TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component ...
Reason: Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, cau...
Z-2397-2021September 8, 2021Warsaw, IN
Merge Healthcare, Inc.
Class IITerminated
Merge Hemo, Software packages 10.2, 10.3, and 10.4
Reason: The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x and 10.x, used in combination with an HL7 lab interface.
Z-2387-2021September 8, 2021Hartland, WI
DePuy Orthopaedics, Inc.
Class IITerminated
TRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component in...
Reason: Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, cau...
Z-2399-2021September 8, 2021Warsaw, IN
DePuy Orthopaedics, Inc.
Class IITerminated
TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component i...
Reason: Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, cau...
Z-2394-2021September 8, 2021Warsaw, IN
DePuy Orthopaedics, Inc.
Class IITerminated
TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component in...
Reason: Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, cau...
Z-2396-2021September 8, 2021Warsaw, IN
Philips Medical Systems Gmbh, DMC
Class IIOngoing
CombiDiagnost R90 Software Version R1.0 and R1.1
Reason: Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter position is changed directly after the Lo...
Z-2357-2021September 8, 2021Hamburg, N/A
Beckman Coulter Inc.
Class IITerminated
Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
Reason: There is a potential that the data management system may add additional cells to the patient request which could lead to erroneous patient result.