Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
Randox Laboratories
Class I - Dangerous
An issue was identified where the software froze during processing of commands, which resulted in no results displayed.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Revolution CT
GE Healthcare
Class I - Dangerous
GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value.
Revolution EVO, Optima CT660, Optima CT680 CT Systems.
GE Healthcare
Class I - Dangerous
Improperly loaded software options may result in additional X -ray radiation exposure to the patient.
Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782
Edwards Lifesciences
Class I - Dangerous
There is a potential that the pressure tubing may detach from the blood sampling system
Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520
Edwards Lifesciences
Class I - Dangerous
There is a potential that the pressure tubing may detach from the blood sampling system
Class I - Dangerous
Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.
Hays Ultrasound kit Item ID: H1000SE
Exact Medical Manufacturing
Class I - Dangerous
No 510k for the product to be used in a natural or surgical opening to the body
6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA
Exact Medical Manufacturing
Class I - Dangerous
No 510k for the product to be used in a natural or surgical opening to the body
Probe Cover, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cover Item ID: 1006576
Exact Medical Manufacturing
Class I - Dangerous
No 510k for the product to be used in a natural or surgical opening to the body
OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326
Cardinal Health
Class I - Dangerous
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N
Exact Medical Manufacturing
Class I - Dangerous
No 510k for the product to be used in a natural or surgical opening to the body
Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N
Exact Medical Manufacturing
Class I - Dangerous
No 510k for the product to be used in a natural or surgical opening to the body
Probe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover Item ID: 1006664
Exact Medical Manufacturing
Class I - Dangerous
No 510k for the product to be used in a natural or surgical opening to the body
Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA
Exact Medical Manufacturing
Class I - Dangerous
No 510k for the product to be used in a natural or surgical opening to the body
novaplus, General Purpose Kit, Cat. No. 56603
Medical Action Industries, Inc. 306
Class I - Dangerous
There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits
DEXCOM G6 SENSOR 3 PACK Item Number: 5447552
Cardinal Health
Class I - Dangerous
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item ID: A-AU-1002N
Exact Medical Manufacturing
Class I - Dangerous
No 510k for the product to be used in a natural or surgical opening to the body
VAPORIZER VICKS 1.5GAL Item Number: 2354942
Cardinal Health
Class I - Dangerous
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
inLight Medical LED Pads used with Polychromatic light technology system
Inlightened Partners
Class I - Dangerous
LED pads with cord connectors that have v-shaped notches may not have been assembled properly. This issue could lead to a power interruption, causing the controller and power supply to shut down.
Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID: E6360
Exact Medical Manufacturing
Class I - Dangerous
No 510k for the product to be used in a natural or surgical opening to the body