Class I - Dangerous
The product do not meet certain internal testing specifications.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the override function.
Arrow Pressure Injectable Two-Lumen PICC Kit 5 Fr. x 50 cm EU-05052-HPMSB
Arrow International
Class I - Dangerous
Product lidstock contains the incorrect expiration date for the product
Arrow EPIDURAL CATHETERIZATION KIT AM-05500
Arrow International
Class I - Dangerous
Product lidstock contains the incorrect expiration date for the product
Class I - Dangerous
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Class I - Dangerous
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Class I - Dangerous
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Class I - Dangerous
A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.
Pentax Video Colonoscope Model: EC34-i10L
Pentax of America
Class I - Dangerous
Distributed in the USA without an approved 510K
Potential exists for one or more axes of the robotic stand to become blocked by their safety brakes; In the event the axis is blocked by its safety brake, the robotic stand can no longer perform the intended movements
Class I - Dangerous
Firm became aware that it distributed 7 units in the U.S. that included a function that had not been cleared by U.S. FDA.
Class I - Dangerous
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
Philips Medical Systems Gmbh, DMC
Class I - Dangerous
When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state, requiring the intervention of a service Engineer. Additionally, the thermos switch, which handles power down of the unit in case of transformer overheating, was installed incorrectly at production.
Class I - Dangerous
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Class I - Dangerous
Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the override function.
Arrow SPINAL ANESTHESIA SET ASA-25090-S
Arrow International
Class I - Dangerous
Product lidstock contains the incorrect expiration date for the product
Class I - Dangerous
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Class I - Dangerous
A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.
The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.