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GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) Discovery NMCT 670 CZT O540+, e) NM/CT 870 CZT CYBER DEFENCE, f) NM/CT 870 CZT O540, g) NM/CT 870 CZT WSO, h) NM/CT 870 CZT, i) NM/CT 870 CZT O540+ 7.25MM; Emission Computed Tomography System

FDA Recall
Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 19, 2022

CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/10/2023: The following FRU and display part numbers have been added as affected devices: (1) Part #2082294-001, FRU MP200 POWER SUPPLY ASSEMBLY; (2) Part #2082293-002-R, FRU MP200 CPU ASSEMBLY; (3) Part #2082293-002, FRU MP200 CPU ASSEMBLY; (4) Part #2071523-001, MP200 22 IN DISPLAY WITH TOUCH; (5) Part #2092930-001, DSP LCD 22 IN MED W/TCH W/DKST N AMR; (6) Part #2092930-002, DSP LCD 22 IN MED W/TCH W/DKST BRIT P/C; (7) Part #2092930-003, DSP LCD 22IN MED W/TCH W/DKST EURO P/C; (8) Part #2092930-004, DSP LCD 22IN MED W/TCH W/DKST ITA P/C; (9), Part #2092930-005, DSP LCD 22IN MED W/TCH W/DKST INDIAN P/C; (10) Part #2092930-006, DSP LCD 22IN MED W/TCH W/DKST ISREAL P/C; (11) Part #2092930-007, DSP LCD 22IN MED W/TCH W/DKST SWISS P/C; (12) Part #2092930-008, DSP LCD 22IN MED W/TCH W/DKST AUSTRL P/C; (13) Part #2092930-009, DSP LCD 22IN MED W/TCH W/DKST JPN; (14) Part #2092930-010, DSP LCD 22IN MED W/TCH W/DKST BRZL P/C; (15) Part #2092930-011, DSP LCD 22IN MED W/TCH W DKST ARGNT P C; (16) Part #2092930-012, DSP LCD 22IN MED W TCH W DKST DENMARK; (17) Part #2092930-013, DSP LCD22IN MED W TCH W DKST S AFRICA P C; and (18) Part #2092930-014, DSP LCD22IN MED W TCH W DKST CHINA P C.

FDA Recall
Open, Classified ·GE Healthcare, LLC·Product code DXJ·May 10, 2022

GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8 inch NM Gantry, d) 860 / Dismount, e) 860 3/8 inch NM Gantry, f) 860 5/8 inch NM Gantry, g) 860 BJ, h) NM 830 3/8 inch BJ, i) NM/CT 850 3/8 inch BJ, j) NM/CT 850 3/8 inch ROW, k) NM/CT 850 3/8 inch ROW_, l) NM/CT 850 CT 850 3/8 inch, m) NM/CT 850 ES 3/8 inch, n) NM/CT 850 ES 3/8 inch ROW, o) NM/CT 860 3/8 inch, p) NM/CT 860 3/8 inch BJ, q) NM/CT 860 3/8 inch ROW, r) NM/CT 860 ADVANCE, s) NM/CT 860 advance 3/8 inch NM Gantry, t) NM/CT 860 BEYOND, u) NM/CT 860 beyond 3/8 inch NM Gantry, v) NM/CT 860 China for China, w) NM/CT 860 CT 860 3/8 inch, x) NM/CT 860 ES 3/8 inch, y) NM/CT 860 ES 3/8 inch ROW, z) NM/CT 850 3/8 inch, aa) NM/CT 850 ES 3/8 inch ROW, bb) NM/CT 860 3/8 inch CH, cc) XELERIS 4 DR WORKSTATION; Emission Computed Tomography System

FDA Recall
Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 19, 2022

Configura Advance Chair, Model Number: CHAIR-0-SC1-030; Advance Chair, 100mm Castors, Std Backrest, Manual; Serial Numbers: 10001-SC1-20 to 10483-SC1-20; 10001-SC1-21 to 10224-SC1-21; 10231-SC1-21 to 10456-SC1-21; 10481-SC1-21 to 10570-SC1-21. Model Number: CHAIR-0-SC2-030; Advance Chair, 100mm (4in) Castors, Std Backrest, Electric; Serial Numbers: 10001-SC2-20 to 10135-SC2-20; 10001-SC2-21 to 10240-SC2-21. Model Number: CHAIR-0-SC3-050; Advance Chair, 125/150mm (5in/6in) Castors, Standard Backrest, Manual; Serial Numbers: 10116-SC3-20 to 10145-SC3-20; 10236-SC3-20 to 10295-SC3-20; 10001-SC3-21 to 10090-SC3-21; 10271-SC3-21 to 10360-SC3-21; 10001-SC3-20 to 10115-SC3-20; 10146-SC3-20 to 10235-SC3-20. Model Number: CHAIR-0-SC4-050; Advance Chair, 125/150mm (5in/6in) Castors, Standard Backrest, Electric; Serial Numbers: 10001-SC4-20 to 10030-SC4-20.

FDA Recall
Open, Classified ·Accora Inc·Product code INM·June 21, 2021

Heron toilet and bath chair Model 880505-01 & 880505-11

FDA Recall
Open, Classified ·Product code INM·June 30, 2017

VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702

FDA Recall
Open, Classified ·Icotec Ag Industriestrasse 12 Altstatten Sg Switzerland·Product code NKB·November 3, 2022

Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controlling or maneuvering a power chair

FDA Recall
Open, Classified ·mo-Vis BVBA Biebuyckstraat 15D Nevele Belgium·Product code KNN·November 28, 2023

Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Air, Adapt Air EX, Adapt Air Pro, Adapt Air Pro EX, Adapt Convertible, Adapt Convertible EX), sofware version 1.3.0; Mattress, Air Flotation, Alternating Pressure

FDA Recall
Open, Classified ·Agiliti Health Ellis·Product code FNM·January 21, 2026

Stryker Arise 1000EX mattress, Part Number 2236000000

FDA Recall
Open, Classified ·Stryker Medical Division of Stryker Corporation·Product code FNM·October 31, 2025

Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-59 (Fix)

FDA Recall
Open, Classified ·Turncare, Inc·Product code FNM·November 1, 2023

Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-69 (Fix)

FDA Recall
Open, Classified ·Turncare, Inc·Product code FNM·August 10, 2023

Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241

FDA Recall
Open, Classified ·Zimmer, Inc.·Product code PHX·May 20, 2026

Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476

FDA Recall
Open, Classified ·Zimmer, Inc.·Product code PHX·May 20, 2026

MiniMed 640G, insulin pump, Ref/Model # MMT-1711K, MMT-1752K, MMT-1752, Rx Only - Product Usage: indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

FDA Recall
Open, Classified ·Medtronic Inc.·Product code N/A·April 30, 2020

Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of the visual axes using polarized light. Model Number BQ830

FDA Recall
Open, Classified ·Rebiscan, Inc.·Product code PMW·October 3, 2022

VIDAS Lyme IgG II (LYM), REF 417401

FDA Recall
Open, Classified ·bioMerieux, Inc.·Product code LSR·September 22, 2021

VIDAS RUB IgG (RBG), REF 30226

FDA Recall
Open, Classified ·bioMerieux, Inc.·Product code LFX·September 22, 2021

VIDAS Lyme IgM II (LYM), REF 416436

FDA Recall
Open, Classified ·bioMerieux, Inc.·Product code LSR·September 22, 2021

VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829

FDA Recall
Open, Classified ·Biomerieux Inc·Product code LON·November 9, 2022

VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217

FDA Recall
Open, Classified ·Biomerieux Inc·Product code LFY·November 9, 2022