125 results · 22ms · Sources: EU EUDAMED, US FDA

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bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.

FDA Recall
Open, Classified ·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·November 30, 2023

bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Recall
Open, Classified ·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025

bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Recall
Open, Classified ·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025

Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Recall
Open, Classified ·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025

bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.

FDA Recall
Open, Classified ·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·September 4, 2024

bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Recall
Open, Classified ·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025

UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Recall
Open, Classified ·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025

1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Recall
Open, Classified ·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025

Trilogy Evo Universal, Product number DS2000X11B

FDA Recall
Open, Classified ·Philips Respironics, Inc.·Product code CBK·July 26, 2021

Puritan Bennett 980 Series Ventilator

FDA Recall
Open, Classified ·Medtronic formerly Covidien Michael Collins Road, Mervue Ind. Park Galway Ireland·Product code CBK·March 25, 2022

Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B, R1054260, RSL1054260, CA1054096, R1054260B, R1054655TPV, AU1054096, AU1054096B, 1054096B, 1054097, BR1054096, LA1054096, CN1054096, KO1054096, KR1054096, R1054655TP, R1054655B, 1054655, 1054655TPV, 1054655TP, 1054655B

FDA Recall
Open, Classified ·Philips Respironics, Inc.·Product code CBK·December 7, 2022

Philips Garbin Ventilator, Model Number 1058180B

FDA Recall
Open, Classified ·Philips Respironics, Inc.·Product code CBK·December 7, 2022

Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes BT-20-0002, BT-20-0002A and BT-20-0002AP. The Life2000 ventilation system includes the Life2000 ventilator which has its individual label.

FDA Recall
Open, Classified ·Baxter Healthcare Corporation·Product code CBK·May 29, 2024

Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, JP2100X16B, AU2100X15B, LA2100X15B, CA2100X12B, CN2100X17B, BR2100X18B, KR2100X15B, IA2100X15B, PP2100X10, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, BL2100X15B, GB2100X15B, EU2100X15B, EU2100X19, EE2100X15B, TR2100X15B, UDS2100X11B, RDS2100X11B, and SP2100X26B

FDA Recall
Open, Classified ·Philips Respironics, Inc.·Product code CBK·March 1, 2023

Trilogy Evo Universal Ventilator, Model No. DS2000X11B

FDA Recall
Open, Classified ·Philips Respironics, Inc.·Product code CBK·July 16, 2024

Servo-n Ventilator System. Model Number: 6694800.

FDA Recall
Open, Classified ·Maquet Critical Care AB Rontgenvagen·Product code CBK·May 30, 2025

NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)

FDA Recall
Open, Classified ·Draeger Medical, Inc.·Product code CBK·January 23, 2023

Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, LA2100X15B, IA2100X15B, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, EU2100X15B, EU2100X19, EE2100X15B, and SP2100X26B

FDA Recall
Open, Classified ·Philips Respironics, Inc.·Product code CBK·May 1, 2023

Ventilator HAMILTON-C6, PN: 160021

FDA Recall
Open, Classified ·Hamilton Medical AG Via Crusch 8 Bonaduz Switzerland·Product code CBK·May 15, 2024

Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.

FDA Recall
Open, Classified ·Philips Respironics, Inc.·Product code CBK·October 7, 2024