Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

2,985 results found for software Page 66 of 120
RAYSEARCH LABORATORIES AB
Class II Terminated
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) . Intended Use: software system designed for treatm...
Reason: When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong
Z-1930-2019 July 10, 2019 Stockholm, N/A
GE Healthcare, LLC
Class II Terminated
Centricity PACS Foundation Centricity PACS software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital...
Reason: There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the arch...
Z-1911-2019 July 10, 2019 Waukesha, WI
Siemens Medical Solutions USA, Inc
Class II Terminated
SOMATOM go.Now, Model No. 11061618 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional im...
Reason: The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.
Z-1920-2019 July 10, 2019 Malvern, PA
Siemens Medical Solutions USA, Inc
Class II Terminated
SOMATOM go.All (Model #11061630), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images...
Reason: The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.
Z-1917-2019 July 10, 2019 Malvern, PA
Siemens Medical Solutions USA, Inc
Class II Terminated
SOMATOM go.Top, Model No. 11061648 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional im...
Reason: The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.
Z-1922-2019 July 10, 2019 Malvern, PA
Siemens Medical Solutions USA, Inc
Class II Terminated
SOMATOM go.All, Model No. 11061638 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional im...
Reason: The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.
Z-1921-2019 July 10, 2019 Malvern, PA
Siemens Medical Solutions USA, Inc
Class II Terminated
SOMATOM go.Now (Model #11061620), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images...
Reason: The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.
Z-1916-2019 July 10, 2019 Malvern, PA
Siemens Medical Solutions USA, Inc
Class II Terminated
SOMATOM go.Up (Model #11061610) with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of...
Reason: The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.
Z-1915-2019 July 10, 2019 Malvern, PA
Hitachi America, Ltd., Power Systems Division
Class II Terminated
PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
Reason: There is a potential for a discrepant target position when using 3D3D matching mode in PIAS (Positioning Image Analysis System) software installed in the PROBEAT-V, proton therapy ...
Z-1892-2019 July 3, 2019 Houston, TX
Arkray Factory USA, Inc.
Class II Terminated
AUTION HYBRID AU-4050
Reason: This correction is being initiated due to a software issue which results in the possibility of incorrect patient information being assigned to sample results when the following rar...
Z-1850-2019 June 26, 2019 Minneapolis, MN
Philips North America, LLC
Class III Terminated
Philips Patient Information Center iX configured with a regional setting which uses a comma for a decimal separator: 866389 Patient Information Center iX B.01 (or later); 866390 Patient Information ...
Reason: Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion pumps transmitted via the HL7 output interface through the Patient Information Cen...
Z-1771-2019 June 19, 2019 Andover, MA
Flowonix Medical Inc
Class II Terminated
Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.
Reason: The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a softwa...
Z-1714-2019 June 12, 2019 Mansfield, MA
Fresenius Medical Care Renal Therapies Group, LLC
Class III Terminated
2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare f...
Reason: Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.
Z-1699-2019 June 12, 2019 Waltham, MA
Angiodynamics Inc. (Navilyst Medical Inc.)
Class II Terminated
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero Generator US PG Catalog Number: 12740000US UPN: H78...
Reason: Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
Z-1700-2019 June 12, 2019 Glens Falls, NY
Angiodynamics Inc. (Navilyst Medical Inc.)
Class II Terminated
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applicator 14cm PG Catalog Number: 700106001 UPN:H7877001060010; (2)Solero Applicator 14cm PG US Catalog Number:700106...
Reason: Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
Z-1702-2019 June 12, 2019 Glens Falls, NY
Flowonix Medical Inc
Class II Terminated
Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal infusion.
Reason: The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a softwa...
Z-1716-2019 June 12, 2019 Mansfield, MA
Angiodynamics Inc. (Navilyst Medical Inc.)
Class II Terminated
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 19cm PG Catalog Number: 700106002 UPN: H7877001060020 (2)Solero Applicator 19cm PG US Catalog Number:7001060...
Reason: Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
Z-1703-2019 June 12, 2019 Glens Falls, NY
Flowonix Medical Inc
Class II Terminated
Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
Reason: The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a softwa...
Z-1712-2019 June 12, 2019 Mansfield, MA
Angiodynamics Inc. (Navilyst Medical Inc.)
Class II Terminated
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Generator Refurbished PG Catalog Number: 12740000D UPN: H78712740000D0 (2) Solero Generator Refurbished US PG Catalog Nu...
Reason: Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
Z-1701-2019 June 12, 2019 Glens Falls, NY
Angiodynamics Inc. (Navilyst Medical Inc.)
Class II Terminated
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog Number:700106003 UPN: H7877001060030 (2)Solero Applicator 29cm PG US Catalog Number:700106003...
Reason: Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
Z-1704-2019 June 12, 2019 Glens Falls, NY
Flowonix Medical Inc
Class II Terminated
Prometra II Programmable Pump, Cat. No. 13827 For intrathecal infusion.
Reason: The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a softwa...
Z-1715-2019 June 12, 2019 Mansfield, MA
Flowonix Medical Inc
Class II Terminated
Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
Reason: The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a softwa...
Z-1713-2019 June 12, 2019 Mansfield, MA
Abbott Laboratories Inc. (St Jude Medical)
Class II Terminated
TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP)
Reason: In reported cases, the device log on the TactiSys Quartz Equipment operating on Software Version 1.7.0 fills the allocated disk space, which prevents the storage of new log data. ...
Z-1493-2019 June 5, 2019 Saint Paul, MN
Neusoft Medical Systems Co., Ltd.
Class II Terminated
NeuViz 64 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube an...
Reason: Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system wh...
Z-1279-2019 May 29, 2019 Shenyang, N/A
Roche Diagnostics Corporation
Class II Terminated
Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use
Reason: Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from the first sample subsequent to the bottle change, (when usin...
Z-1368-2019 May 29, 2019 Indianapolis, IN