Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ programs (OGPs) the collimation may be incorrect.
Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R,...
Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements have not been tested or validated for accuracy. If healthcare providers base clinical judgment on unvalidated measurements, this could potentially lead to incorrect clinical decisions.
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoas...
Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
Devices are not suitable for organ transplant.
Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.
It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly.
The AlignRT InBore system contains six Class 1 lasers which enables the system s...
Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers and their characteristics was omitted from the Instructions for Use for the subject system as required by 21 CFR 1040,10(h), via conformance with recognized consensus standard IEC 60825-1 Ed. 3 (FDA Laser Notice 56).
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revog...
The affected lots show a decline in performance over time, which may lead to false-negative results.
Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1....
Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots to (1) not transmit a low battery alert to the Arial Wireless Emergency Call System prior to battery failure, or (2) not transmit a low battery alert to the Arial Wireless Emergency Call system at least seven (7) days prior to the battery failing.
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressur...
Customer complaints of Pressio monitor rebooting.
Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND...
Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may experience shortness of breath leading to hypoxia, which may require medical intervention to prevent further respiratory deterioration.
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
Devices are not suitable for organ transplant.
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Device packaged in incorrect outer box carton.
Philips Incisive CT
Potential for incomplete scan due to unstable connection inside of floating sensor.
Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
Devices are not suitable for organ transplant.
Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MI...
Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman Cer...
Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; ...
Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.
Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6....
Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots to (1) not transmit a low battery alert to the Arial Wireless Emergency Call System prior to battery failure, or (2) not transmit a low battery alert to the Arial Wireless Emergency Call system at least seven (7) days prior to the battery failing.
Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Num...
Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury.
Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable results in non-conformance to the design specifications, which require two ferrites (one at each end of the cable).
Material Processing Laser Products
Lack of Remote Interlock Connector - required per 21 CFR 1040.10(f)(3)
Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (...
Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.