Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

2,985 results found for software Page 13 of 120
Baxter Healthcare Corporation
Class I Ongoing
Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump
Reason: Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that ...
Z-2334-2025 September 10, 2025 Deerfield, IL
RAYSEARCH LABORATORIES AB
Class II Ongoing
RayStation with the following product descriptions: 1. RayStation 7, Software Version: 7.0.0.19. 2. RayStation 8A, Software Version: 8.0.0.61. 3. RayStation 8A Service Pack 1, Software Versi...
Reason: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Z-2487-2025 September 10, 2025 Stockholm, N/A
RAYSEARCH LABORATORIES AB
Class II Ongoing
RayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933. 2. RayStation 9B Service Pack 1, Software Version: 9.2.0.483. 3. RayStation 10A, Software V...
Reason: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Z-2489-2025 September 10, 2025 Stockholm, N/A
mo-Vis BVBA
Class I Ongoing
IDM-MULTI-R. Electrical wheelchair component.
Reason: Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair ...
Z-2457-2025 September 10, 2025 Nevele, N/A
Baxter Healthcare Corporation
Class I Ongoing
Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
Reason: Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that ...
Z-2333-2025 September 10, 2025 Deerfield, IL
Merge Healthcare, Inc.
Class II Ongoing
Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that m...
Reason: Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where certain units trigger an error mes...
Z-2518-2025 September 10, 2025 Hartland, WI
RAYSEARCH LABORATORIES AB
Class II Ongoing
RayStation with the following product descriptions: 1. RayStation 2023B, Software Version: 14.0.0.3338. 2. RayStation 2024A, Software Version: 15.0.0.430. 3. RayStation 2024A SP3, Software V...
Reason: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Z-2495-2025 September 10, 2025 Stockholm, N/A
RAYSEARCH LABORATORIES AB
Class II Ongoing
RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStation 10B Service Pack 1, Software Version: 10.1.1.54. Product Description: Rad...
Reason: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Z-2490-2025 September 10, 2025 Stockholm, N/A
Reflexion Medical, Inc.
Class II Ongoing
RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 (01)00860003983812(11)230505(21)X11003 (01)00860003983812(11)230530(21)X11004 ...
Reason: Due to incorrect software configuration that potentially allows more than two (2) fractions within a 12-hour period (fractionLimits) and could potentially lead to adverse events (t...
Z-2486-2025 September 10, 2025 Hayward, CA
mo-Vis BVBA
Class I Ongoing
Multi Joystick R-net. Electrical wheelchair component.
Reason: Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair ...
Z-2455-2025 September 10, 2025 Nevele, N/A
RAYSEARCH LABORATORIES AB
Class II Ongoing
RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2. 2. RayStation 6 Service Pack 2, Software Version: 6.2.0.7. 3. RayStation 6 Serv...
Reason: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Z-2494-2025 September 10, 2025 Stockholm, N/A
Dexcom, Inc.
Class I Ongoing
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.4.0 and earlier Product Description: D...
Reason: The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM...
Z-2450-2025 September 10, 2025 San Diego, CA
RAYSEARCH LABORATORIES AB
Class II Ongoing
RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStation 12A Service Pack 1, Software Version: 13.1.0.144. 3. RayStation 12A Servic...
Reason: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Z-2493-2025 September 10, 2025 Stockholm, N/A
mo-Vis BVBA
Class I Ongoing
IDM-MICRO-R. Electrical wheelchair component.
Reason: Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair ...
Z-2456-2025 September 10, 2025 Nevele, N/A
RAYSEARCH LABORATORIES AB
Class II Ongoing
RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pack 1, Software Version: 12.1.0.1221. 3. RayStation 11B Servic...
Reason: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Z-2492-2025 September 10, 2025 Stockholm, N/A
Dexcom, Inc.
Class I Ongoing
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: versions 2.8.0 and earlier Product Description: D...
Reason: The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM...
Z-2448-2025 September 10, 2025 San Diego, CA
Medtronic MiniMed, Inc.
Class II Ongoing
InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
Reason: Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recommen...
Z-2496-2025 September 10, 2025 Northridge, CA
mo-Vis BVBA
Class I Ongoing
All-round Joystick R-net Light. Electrical wheelchair component.
Reason: Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair ...
Z-2458-2025 September 10, 2025 Nevele, N/A
RAYSEARCH LABORATORIES AB
Class II Ongoing
RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.951. 2. RayStation 11A Service Pack 1, Software Version: 11.0.1.29. 3. RayStation 11A Service ...
Reason: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Z-2491-2025 September 10, 2025 Stockholm, N/A
Lumicell, Inc.
Class II Ongoing
Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Model/Catalog Number: 900-00218 Sterile Cover 10-Pack Shipper Box ...
Reason: The potential of the elastic bands included in the kit detaching or fracturing during surgical procedures. As a result, these failures may pose a risk of retained foreign bodies in...
Z-2519-2025 September 10, 2025 Newton, MA
MAQUET GMBH
Class II Ongoing
Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions.
Reason: Under certain conditions, such as the simultaneous use of the operating table with other medical devices, including high-frequency (HF) surgical equipment, interference may occur t...
Z-2420-2025 September 3, 2025 Rastatt
THOR Photomedicine Ltd
Class II Ongoing
Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visib...
Reason: The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
Z-2419-2025 September 3, 2025 Amersham
THOR Photomedicine Ltd
Class II Ongoing
Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectr...
Reason: The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
Z-2416-2025 September 3, 2025 Amersham
THOR Photomedicine Ltd
Class II Ongoing
Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visib...
Reason: The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
Z-2418-2025 September 3, 2025 Amersham
THOR Photomedicine Ltd
Class II Ongoing
Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spe...
Reason: The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
Z-2417-2025 September 3, 2025 Amersham