FDA Device Recalls

Class IIOngoing

Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, S2000, S1610 multimodal imaging platform optimized for the posterior segment of the eye

Heidelberg Engineering GmbH

Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a result. Falling stand may cause impact or crushing injuries, particularly to the feet, legs, hands or arms of the operator or nearby persons.

August 6, 2026 · DeviceView details →

Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);

Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x

PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2. ARD567501286;

Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234

Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.

Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1. 24FR(8124), 2. 28FR(8128), 3. 32FR(8132), 4. 36FR(8136);

ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the ORT200 50/60Hz Covered Table Assy V2 Part Number 114148-000

ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600

LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions (Current 7.8)

Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA

Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, S2000, S1610 multimodal imaging platform optimized for the posterior segment of the eye

LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7)

LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Versions (Current 7.7)

MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201

Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)

MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))

Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25