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Siemens Medical Solutions USA, Inc: SOMATOM Confidence -Computed tomography systems Model 105...
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
FDANov 19, 2021Nationwide• Siemens Medical Solutions USA, Inc
Siemens Medical Solutions USA, Inc: SOMATOM Definition Edge -Computed tomography system Model...
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
FDANov 19, 2021Nationwide• Siemens Medical Solutions USA, Inc

Datascope Corp.: Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers...
Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.
FDANov 15, 2021Nationwide• Datascope Corp.

Datascope Corp.: Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers...
Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.
FDANov 15, 2021Nationwide• Datascope Corp.

Acclarent, Inc.: TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 7...
Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for visual verification of device location in the patient anatomy. If the surgeon does not detect the accuracy error, this could lead to an intraprocedural delay, a potential for reversible tissue damage or damage to the carotid artery, CSF leak, or damage to optic nerve.
FDANov 12, 2021AL, AZ, CA +36 more• Acclarent, Inc.

Beckman Coulter Inc.: SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Low quality control recovery failures may be observed after passing calibration. Brown particulates in compartment C of the reagent cartridge may be observed. Continued use may lead to, 1) failed QC and/or calibrations, 2) Erroneous low Cholesterol patient results.
FDANov 10, 2021Nationwide• Beckman Coulter Inc.

Siemens Healthcare Diagnostics, Inc.: Aptio Automation Interface Module to ADVIA Centaur XP/XPT...
The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cases, to an incorrect association of test results to sample ID. Incorrect association of test results could impact clinical interpretations and clinical decisions.
FDAOct 6, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Abbott Laboratories: ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i...
Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, loss of module communication leading to overfilling wash buffer containers, missing QC flags, signal spikes, abnormal optics reads, and incorrect sample aspiration. The issues may lead to inaccurate results with an unknown bias direction and magnitude for assays measuring cardiac, metabolic (including diabetes), toxicology, prenatal, therapeutic drug monitoring, infectious disease, oncology, hepatic, pancreatic, hematological, endocrinologic, inflammatory analytes.
FDASep 29, 2021AL, AK, AZ +47 more• Abbott Laboratories

CooperSurgical, Inc.: LEEP PRECISION Generator 120V Cooper Surgical Part Number...
Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.
FDASep 29, 2021Nationwide• CooperSurgical, Inc.

CooperSurgical, Inc.: Quantum 2000 Electrosurgical Generators Cooper Surgical P...
Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.
FDASep 29, 2021Nationwide• CooperSurgical, Inc.

Abbott Laboratories: ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ...
Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, loss of module communication leading to overfilling wash buffer containers, missing QC flags, signal spikes, abnormal optics reads, and incorrect sample aspiration. The issues may lead to inaccurate results with an unknown bias direction and magnitude for assays measuring cardiac, metabolic (including diabetes), toxicology, prenatal, therapeutic drug monitoring, infectious disease, oncology, hepatic, pancreatic, hematological, endocrinologic, inflammatory analytes.
FDASep 29, 2021AL, AK, AZ +47 more• Abbott Laboratories

CooperSurgical, Inc.: LEEP PRECISION Integrated System, 120V CooperSurgical par...
Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.
FDASep 29, 2021Nationwide• CooperSurgical, Inc.

CooperSurgical, Inc.: LEEP PRECISION Generator 220V Cooper Surgical Part Number...
Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.
FDASep 29, 2021Nationwide• CooperSurgical, Inc.

bioMerieux, Inc.: VIDAS FSH, REF 30407-01
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
FDASep 22, 2021Nationwide• bioMerieux, Inc.

bioMerieux, Inc.: VIDAS Lyme IgG II (LYM), REF 417401
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
FDASep 22, 2021Nationwide• bioMerieux, Inc.

bioMerieux, Inc.: VIDAS PRG Progesterone, REF 30409-01
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
FDASep 22, 2021Nationwide• bioMerieux, Inc.

bioMerieux, Inc.: VIDAS Lyme IgM II (LYM), REF 416436
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
FDASep 22, 2021Nationwide• bioMerieux, Inc.

bioMerieux, Inc.: VIDAS DEX@, Dimer Exclusion II, REF 30455-01
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
FDASep 22, 2021Nationwide• bioMerieux, Inc.