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Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope. It has been assigned the product code FSO by the FDA and is classified as a Class I medical device. Intended for improving the visibility of objects through magnification and illumination.
FDA Recall
Terminated
·Leica Microsystems, Inc.·Product code FSO·January 11, 2016
Touch Panel/Control Unit Carrier of the Swingarm M820/M844 C19, article no. 10448194MO; a component of the Leica M820 C19 Surgical Microscope, article 10448196, and the Leica M844 C19 Surgical Microscope, article 10448197; ceiling mounted surgical microscopes; Leica Microsystems (Schweiz) AG, Max Schmidheiny-Strasse 201, CH-9425, Heerbrugg, Switzerland;; The intended use of the microscope is for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.
FDA Recall
Terminated
·Leica Microsystems, Inc.·Product code FSO·February 27, 2012
Leica Footswitch, Type B used in conjunction with Leica Surgical Microscopes - Models M620, M844/820, M525 and M720; There are three cable connection footswitch models : a) MFS11, stock number 10445599, a 6 function footswitch type B with cross pedals; b) MFS12, stock number 10445600, a 12 function footswitch type B with cross pedals, XY-actuator 10717602 and screw 10630134 for dust protection enclosed; c) MFS18, stock number 10448164, a 16 function footswitch type B with cross pedals, XY-actuator 10717602 and screw 10630134 for dust protection enclosed;
FDA Recall
Terminated
·Leica Microsystems, Inc.·Product code FSO·March 29, 2010
Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz) Ag, 201 Max Schmidheiny Strasse, Heerbrugg, Switzerland Product Usage: The intended use of this device is for improving visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.
FDA Recall
Terminated
·Leica Microsystems, Inc.·Product code FSO·June 4, 2012
Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950
FDA Recall
Open, Classified
·Leica Microsystems, Inc.·Product code FSO·August 26, 2022
Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
FDA Recall
Open, Classified
·Leica Microsystems, Inc.·Product code FSO·August 26, 2022
OPMI LUMERA 300, REF 6137
FDA Recall
Open, Classified
·Carl Zeiss Suzhou Co., Ltd. Modern Industrial Square·Product code FSO·August 18, 2023
Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.
FDA Recall
Terminated
·Leica Microsystems (Schweiz) Ag 201 Max Schmidheiny-Strasse Heerbrugg Switzerland·Product code FSO·December 18, 2012
Aeos Robotic Digital Microscope, Product Code: PV010
FDA Recall
Open, Classified
·Aesculap Inc·Product code FSO·May 13, 2024
Leica Surgical Operating Microscopes, Arveo, Part Number 10448999
FDA Recall
Open, Classified
·Leica Microsystems, Inc.·Product code FSO·August 26, 2022
Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737
FDA Recall
Open, Classified
·Leica Microsystems, Inc.·Product code FSO·August 26, 2022
Aeos Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
FDA Recall
Terminated
·Aesculap Implant Systems LLC·Product code FSO·July 14, 2022
Leica Wireless Footswitch, Type B used in conjunction with Leica Surgical Microscopes - Models M620, M844/820, M525 and M720; There are two wireless models: a) MFS20, stock number 10448406, a 12 function wireless footswitch type B with cross pedals, XY-actuator 10717602 and screw 10630134 for dust protection enclosed; b) MFS21, stock number 10448407, a 16 function wireless footswitch type B with cross pedals, XY-actuator 10717602 and screw 10630134 for dust protection enclosed;
FDA Recall
Terminated
·Leica Microsystems, Inc.·Product code FSO·March 29, 2010
MicroScan Lens Disposable Plastic Cap used with MicroScan Video Microscope, MicroVisionMedical brand
FDA Recall
Terminated
·Microvision Medical Holding B.V. Meibergdreef 45 Amsterdam Netherlands·Product code FSO·July 21, 2006
Leica Microsystems M220 F12 Microscope Systems
FDA Recall
Terminated
·Leica Microsystems, Inc.·Product code FSO·November 3, 2021
Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.
FDA Recall
Terminated
·Leica Microsystems (Schweiz) Ag 201 Max Schmidheiny-Strasse Heerbrugg Switzerland·Product code FSO·December 18, 2012
Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
FDA Recall
Completed
·Aesculap Implant Systems LLC·Product code FSO·February 19, 2021
(1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in. x 9 in. per box, ASO Item No. 781083, SKU 894111 (2) CVS Health 30 Piece Wound Care Kit, For Large Size Wounds, ASO Item No. 781240, SKU 998842; and (3) equate First Aid Kit, 120 Items, containing 1 generic Sterile Trauma Pad 5 in. x 9 in., ASO Item No. 192636, SKU #30174479.
FDA Recall
Open, Classified
·ASO LLC·Product code FQM·June 22, 2022
SoftWeb version 4.0.4.10.1. SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. Manufacture Date: 05/16/2006.
FDA Recall
Terminated
·SCC Soft Computer·Product code LNX·June 8, 2006
Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgM, Prealbumin, RF and Transferrin assays Catalogue Number: IT2691
FDA Recall
Open, Classified
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JIX·July 19, 2023