GE Healthcare Optima CT520 X-ray system recall — FDA Z-2185-2017
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
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It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these…
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.
The firm was notified that the product may be potentially contaminated with Listeria monocytogenes.
According to the firm, they have detected metal in their product. The firm learned of the problem through an internal verification techniques. The firm believes there is a risk of a health…
According to the firm, they have detected metal in their product. The firm learned of the problem through an internal verification techniques. The firm believes there is a risk of a health…
According to the firm, they have detected metal in their product. The firm learned of the problem through an internal verification techniques. The firm believes there is a risk of a health…
According to the firm, they have detected metal in their product. The firm learned of the problem through an internal verification techniques. The firm believes there is a risk of a health…
According to the firm, they have detected metal in their product. The firm learned of the problem through an internal verification techniques. The firm believes there is a risk of a health…
According to the firm, they have detected metal in their product. The firm learned of the problem through an internal verification techniques. The firm believes there is a risk of a health…
The firm received notification from their supplier of possible listeria contamination.
According to the firm, they have detected metal in their product. The firm learned of the problem through an internal verification techniques. The firm believes there is a risk of a health…
According to the firm, they have detected metal in their product. The firm learned of the problem through an internal verification techniques. The firm believes there is a risk of a health…
According to the firm, they have detected metal in their product. The firm learned of the problem through an internal verification techniques. The firm believes there is a risk of a health…
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