The identified problem is an erroneous association between the carrier and the sample tube caused by a communication error between the firmware of the Interface Modules and the Automation software. This problem can occur only when one of these Interface Modules is put off-line after a carrier in their secondary lane is physically returned on the main track and then put back on-line when the carrier is used to transport another tube.
All Recalls
95,025 total recalls in our database
🏥 Medical Devices Class I - Dangerous
There is a potential for thrombus formation on balloons prepped and staged in the vasculature for long durations. All users, such as those performing lead extraction cases may not be aware of this risk. It was determined that current labeling is insufficient to ensure all potential users minimize the time the balloon remains in vasculature. If left in too long it could lead to embolization.
🏥 Medical Devices Class I - Dangerous
The firm discovered a potential manufacturing deviation of the yoke of the Body Weight Support (BWS) Light that in rare occasions may result in the yoke detaching from the cable guide.
🏥 Medical Devices Class I - Dangerous
Potential presence of elevated endotoxin levels that exceed the specification limit
Potential presence of elevated endotoxin levels that exceed the specification limit
Potential presence of elevated endotoxin levels that exceed the specification limit
Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147
Applied Medical Resources
🏥 Medical Devices Class I - Dangerous
There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.
🏥 Medical Devices Class I - Dangerous
Potential presence of elevated endotoxin levels that exceed the specification limit
Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225.
Nikon Metrology
🏥 Medical Devices Class I - Dangerous
The manufacturer identified a risk that their products might fail to comply with the cabinet x-ray system performance standard limit on x-ray emissions [21 CFR 1020.40(c)(1)] due to an insufficient safety margin for the means of attachment of a piece of interior x-ray shielding. Double sided industrial tape was used for attachment - there have been only 2 instances of detachment and although the piece of shielding detached it remained mostly in place supported by wires that pass through that piece of shielding. The repair is accomplished by adding a bracket to fasten the piece of shielding securely to the inside of the x-ray system. Mfr reports that no systems were found to have exceeded the emission limit when checked prior to repair.
Potential presence of elevated endotoxin levels that exceed the specification limit
Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector. This can result in an electrical shock if the user or other persons touch the contact pins of the X10 connector.
Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Product Code 775100
Cardinal Health
🏥 Medical Devices Class I - Dangerous
The feeding spike sets may leak at the interface of the tube and spike connector.
🏥 Medical Devices Class I - Dangerous
The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.
da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
Intuitive Surgical
🏥 Medical Devices Class I - Dangerous
Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may affect image quality resulting in needing to switch to a second camera or converting to another surgical modality. If residual soil makes contact with the patient, exposure could result in sensitization making future component blood therapy or tissue typing more challenging; additionally if a small piece of inert epoxy were to be retained, scar tissue could form.
Potential presence of elevated endotoxin levels that exceed the specification limit
🏥 Medical Devices Class I - Dangerous
Potential presence of elevated endotoxin levels that exceed the specification limit
🏥 Medical Devices Class I - Dangerous
The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
🏥 Medical Devices Class I - Dangerous
HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections
Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154
Applied Medical Resources
🏥 Medical Devices Class I - Dangerous
There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.