Other Medical Devices

Merge is conducting a hardware recall (replacement) of Fellows "Mighty 8" Power Strip and TrippLite Power Strip due to overheat of input resistor causing the power strip to smoke.

Issue related to the performance of the motor in recalled product. During use, motor may cease to function.

Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal end of the instrument.

Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.

On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing, Lot number 1.042/16 the firm found 701 out of 3,195 were rejected due to visual defect, gap in the supplier s manufacturing seal for Part number #317036 5 X 6.5 ST Bag Combo. the firm decided to recall Precision Flow Rate Tubing and RMS HIgH-Flo Subcutaneous Safety Needles Sets due to the sterile barrier packaging being found to have gaps during post-sterilization inspection of one lot of flow tubing, in which 701 out of 3,195 units were rejected for not passing inspection. The firm determined that the issue was large than just the one lot and recalled the product via March 10, 2016 Voluntary Medical Device Corrections and Removal Notification to customers. The recall was conducted without FDA notification.

Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 mm in length.

Due to a human error at a supplier, an unknown number of devices within one specific production lot of Brainlab DrapeLink Adapters (Left/Right) were not manufactured according to defined specifications.

There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry.

There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry.

There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry.

The 30 minute maximum tanning time has been reduced to 20 minutes.

The tube adapter-plate green/yellow protective earthing (PE) wire was removed. and spacers with different thickness were used to position pre-loc ring in respect to focal spot in specified distance.

Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

Device was distributed with the etching missing from the product.

Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.