64 results
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14ms
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Sources: EU EUDAMED, US FDA
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Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
FDA Recall
Open, Classified
·SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel·Product code GKZ·June 14, 2022
The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fashion. Using dedicated staining, the proposed platform provides complete blood count analysis. The Sight OLO is a compact device, designed to be automated and simple to operate, to enable rapid testing and analysis. The Sight OLO consists of a scanning and analyzing device and a CBC test kit, including disposable cartridges and sample preparation tools. The disposable cartridge containing the blood sample is loaded into the device through the loading slot. The device is operated through the touch screen interface. The Sight OLO provides complete blood count information with 5-part differentials for white blood cell types. Specifically, the CBC parameters measured by the Sight OLO are listed below and include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, NEUT%/#, LYMPH %/#, MONO %/#, EO%/# and BASO%/#. In addition, the Sight OLO signals specific WBC abnormal cases by flagging the sample.
FDA Recall
Open, Classified
·SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel·Product code GKZ·January 20, 2022
Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
FDA Recall
Open, Classified
·SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel·Product code GKZ·May 13, 2024
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.1 + PKA 3.0.2 + MGO 1.2.2 Application Part Number: 700001590414
FDA Recall
Open, Classified
·Stryker Orthopaedics·Product code OLO·April 15, 2024
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 Software: TKA 2.0.de.1+TKA 1.0.1.de.1+PKA3.0.2.de. Application Part Number: 700002190743-03
FDA Recall
Open, Classified
·Stryker Orthopaedics·Product code OLO·April 15, 2024
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System
FDA Recall
Open, Classified
·Orthalign, Inc·Product code OLO·February 10, 2026
NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
FDA Recall
Open, Classified
·NuVasive Inc·Product code OLO·July 19, 2022
CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S
FDA Recall
Open, Classified
·Blue Belt Technologies, Inc·Product code OLO·November 13, 2023
Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
FDA Recall
Open, Classified
·Product code OLO·July 17, 2024
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code OLO·August 7, 2024
stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
FDA Recall
Open, Classified
·Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France·Product code OLO·March 5, 2025
stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
FDA Recall
Open, Classified
·Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France·Product code OLO·March 5, 2025
Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C
FDA Recall
Open, Classified
·Kico Knee Innovation Company·Product code OLO·April 23, 2026
MICS3 Angled Sagittal Saw Attachment; Part Number: 210490
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code OLO·February 2, 2026
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.
FDA Recall
Open, Classified
·Medtronic Navigation, Inc.·Product code OLO·August 22, 2024
Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.
FDA Recall
Open, Classified
·Mako Surgical Corporation·Product code OLO·August 8, 2022
Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.
FDA Recall
Open, Classified
·Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France·Product code OLO·December 18, 2024
CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
FDA Recall
Open, Classified
·Medtronic Sofamor Danek USA, Inc·Product code OLO·July 12, 2023
MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
FDA Recall
Open, Classified
·Product code OLO·September 5, 2023
stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
FDA Recall
Open, Classified
·Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France·Product code OLO·March 5, 2025