Philips X5-1 Transducer.
Philips Ultrasound
Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
interventional fluoroscopic x-ray system
Siemens Medical Solutions USA
Class I - Dangerous
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
Philips S8-3t Transducer.
Philips Ultrasound
Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
Philips XL14-3 Transducer.
Philips Ultrasound
Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
Philips C5-1 Transducer.
Philips Ultrasound
Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
Class I - Dangerous
Cather packaging may contain the incorrect French size.
Philips L12-4 Transducer.
Philips Ultrasound
Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
Servo-n Ventilator System. Model Number: 6694800.
Maquet Critical Care AB
Class I - Dangerous
Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
Change Healthcare Cardiology Hemo Software
CHANGE HEALTHCARE CANADA COMPANY
Class I - Dangerous
Due to complaints, software update may cause software to unexpectedly shutdown.
interventional fluoroscopic x-ray system
Siemens Medical Solutions USA
Class I - Dangerous
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
Class I - Dangerous
This device does not indicate for use in patients with respiratory failure.
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
interventional fluoroscopic x-ray system
Siemens Medical Solutions USA
Class I - Dangerous
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
Class I - Dangerous
Required inspections were not performed on finished product prior to release and distribution.
HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
Hardy Diagnostics
Class I - Dangerous
Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation.
Becton, Dickinson and Company, BD Bio Sciences
Class I - Dangerous
Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)
Siemens Healthcare Diagnostics
Class I - Dangerous
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
Philips VL13-5 Transducer.
Philips Ultrasound
Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
Philips L8-4 Transducer.
Philips Ultrasound
Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
Class I - Dangerous
Cather packaging may contain the incorrect French size.