Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

2,985 results found for software Page 50 of 120
Philips North America Llc
Class II Terminated
Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system
Reason: When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased con...
Z-2315-2021 August 25, 2021 Cambridge, MA
Philips North America Llc
Class II Terminated
728333 Spectral CT 7500 -Computed Tomography X-ray system
Reason: When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased con...
Z-2318-2021 August 25, 2021 Cambridge, MA
Philips Respironics, Inc.
Class II Ongoing
Trilogy Evo Universal, Product number DS2000X11B
Reason: Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the se...
Z-2290-2021 August 25, 2021 Murrysville, PA
Philips Respironics, Inc.
Class II Ongoing
Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B
Reason: Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the se...
Z-2289-2021 August 25, 2021 Murrysville, PA
Philips Respironics, Inc.
Class II Ongoing
Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IN2110X19, IT2110X21B, KR211...
Reason: Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the se...
Z-2287-2021 August 25, 2021 Murrysville, PA
Philips North America Llc
Class II Terminated
728332 IQon Spectral CT-Computed Tomography X-ray system
Reason: When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased con...
Z-2317-2021 August 25, 2021 Cambridge, MA
Philips North America Llc
Class II Terminated
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
Reason: When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased con...
Z-2314-2021 August 25, 2021 Cambridge, MA
Philips North America Llc
Class II Terminated
728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
Reason: When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased con...
Z-2316-2021 August 25, 2021 Cambridge, MA
Philips Respironics, Inc.
Class II Ongoing
Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, R...
Reason: Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the se...
Z-2288-2021 August 25, 2021 Murrysville, PA
Baxter Healthcare Corporation
Class I Terminated
Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
Reason: System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted ...
Z-2110-2021 August 18, 2021 Deerfield, IL
Abbott Laboratories, Inc
Class II Ongoing
Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and re...
Reason: A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.
Z-2276-2021 August 18, 2021 Irving, TX
Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
Class II Terminated
Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
Reason: A issue (bug) has been identified with the interface and image software which could result in anatomical orientation tags/labels being displayed incorrectly. This could result in ...
Z-2254-2021 August 18, 2021 Exeter, N/A
Baxter Healthcare Corporation
Class I Terminated
Dose IQ Safety Software used with Spectrum IQ Infusion Pump
Reason: Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose IQ user interface (UI) and the binary drug library (BDL) loaded onto the Spectrum I...
Z-2165-2021 August 18, 2021 Deerfield, IL
Beckman Coulter, Inc.
Class II Ongoing
Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual License C10575 - Kaluza C Single User 1-year License C10576 - Kaluza C 10 User Network Li...
Reason: Software anomalies that may lead to the generation of erroneous results.
Z-2241-2021 August 18, 2021 Miami, FL
Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
Class II Terminated
Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
Reason: A issue (bug) has been identified with the interface and image software which could result in anatomical orientation tags/labels being displayed incorrectly. This could result in ...
Z-2253-2021 August 18, 2021 Exeter, N/A
BioMerieux SA
Class II Terminated
MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data.
Reason: Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.
Z-2225-2021 August 18, 2021 Marcy L'Etoile, N/A
Caption Health
Class II Terminated
Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0)
Reason: The firm is aware of a issue with ultrasound software that results in unintended video frames being included. This could lead to an incorrect automated ejection fraction (AutoE...
Z-2111-2021 July 28, 2021 Brisbane, CA
Respironics California, LLC
Class I Ongoing
Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is int...
Reason: It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits the amount of press...
Z-2074-2021 July 28, 2021 Carlsbad, CA
Soft Computer Consultants, Inc.
Class II Terminated
SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory se...
Reason: Software showing wrong results reported, PDF not match HIS.
Z-2093-2021 July 28, 2021 Clearwater, FL
Respironics California, LLC
Class I Ongoing
Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended...
Reason: It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits the amount of press...
Z-2073-2021 July 28, 2021 Carlsbad, CA
Soft Computer Consultants, Inc.
Class II Terminated
SoftCytogenetics
Reason: Software is given wrong results going out to HIS on test that had reruns.
Z-2098-2021 July 28, 2021 Clearwater, FL
C-RAD POSITIONING AB
Class II Terminated
PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
Reason: PC Application Software c4D not changing Site upon synchronization during the Setup workflow step
Z-2075-2021 July 21, 2021 Uppsala
Randox Laboratories Ltd.
Class II Terminated
Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
Reason: An issue was identified where the software froze during processing of commands, which resulted in no results displayed.
Z-2013-2021 July 14, 2021 Crumlin (North)
Siemens Medical Solutions USA, Inc
Class II Ongoing
ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
Reason: Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a stepped peripheral imaging (PERISTEPPING/PERIVISION), the C-arm may leave its inten...
Z-2029-2021 July 14, 2021 Malvern, PA
Siemens Healthcare Diagnostics, Inc.
Class II Terminated
The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in rand...
Reason: ADVIA Chemistry System and Software Versions (V1.4 SMN 11314625 and V1.4 China SMN 11316885) may not be aligned with customer expectations for the current default mixer failure det...
Z-2014-2021 July 14, 2021 Tarrytown, NY