Medical Devices Recalls

Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. The firm has identified systems that may be at risk for this failure due to the collimator compensator being past its lifetime expected usage.

There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal simultaneously.

The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU

The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU

New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D modules which may have potential medical risk. ***Update: Cobas c111 and COBAS INTEGRA 400 plus analyzers are also impacted for BILT3 and LACT2 assays***

There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.

The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the specified lots of the product.

The kits were prepared with incorrect patient ID labels and may contain incorrect components.

Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The images acquired using these protocols do not represent the average position of the anatomy during the respiratory motion cycle. The images are based on data acquired around full expiration. 2) The display of the images in the Elekta Unity Application software does not provide information about the protocol used to acquire the image eg. with or without respiratory triggering. Users must select an appropriate scan protocol that is representative of the respiratory phase used in the reference plan.

The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.

COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over

For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).

There is the potential for debris/material to be found behind the O-rings in the neck trials.

One lot of ACUVUE OASYS¿ for ASTIGMATISM Brand Contact lenses has the potential for a limited number of individual contact lens packages to have an incomplete packaging seal.

DualStop Caps defect causing leaks in affected product

Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F

Certain Torque Limiting Handles in the field are beyond their 3 year calibration life.

There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.

The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.

The luer could break and cause the device to leak or break off and get stuck in the fistula needle port rendering the port inaccessible for dialysis. As a result, the patient would need to be re-cannulated with a new fistula needle to obtain their dialysis treatment.