| |
Class 2 Device Recall Interventional Fluoroscopic Xray System |
 |
| Date Initiated by Firm |
February 02, 2022 |
| Create Date |
April 06, 2022 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-0874-2022 |
| Recall Event ID |
89787 |
| 510(K)Number |
K170144 K141979 K172822 K181830
|
| Product Classification |
System, image processing, radiological - Product Code LLZ
|
| Product |
Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) running StentBoost Live (Model Number 459801781661) Software Version Number: R2.0 |
| Code Information |
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(01)00884838099241(21)115;
Serial Numbers: 839
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8
9
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551
23
26
178
179
115
|
Recalling Firm/
Manufacturer |
Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
|
Manufacturer Reason
for Recall |
Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a previous run. The image shown could be from the same patient or from a different patient.
|
FDA Determined
Cause 2 |
Under Investigation by firm |
| Action |
Urgent Medical Device Correction notification letters dated 2/2/22 were distributed to customers.
1. What is the problem and under what circumstances it can occur
Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a previous run. The image shown could be from the same patient or from a different patient.
When the problem occurs, the area of the boosted images remains black, and the small X-ray viewer in the upper right corner will show a single static image of the previous run. The correct patient information is shown on the Philips Allura/ Azurion system. This defect is intermittent and is caused by a race condition when the software does not properly handle all the "process requests".
This problem has been identified through the investigation of 2 (two) customer complaints.
2. What is the hazard/harm assoclated with this issue
The incorrect image displayed to the user could lead to incorrect treatment. If the problem occurs, the Stent8oost Live application will have to be restarted (see action 4), causing a delay in the procedure.
To date, Philips has not received any reports of harm associated with this problem.
3. Affected products and how to identify them The Philips StentBoost Live R2.0 used with Philips Allura and Azurion systems is affected by this issue. The software version of the Philips StentBoost Live application can be seen by clicking on the "About" box displayed when the application is opened (see Fig. 1 and 2).
|
| Quantity in Commerce |
338 |
| Distribution |
Global Distribution. US Nationwide. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database |
510(K)s with Product Code = LLZ and Original Applicant = Philips Medical Stystems Nederland BV
510(K)s with Product Code = LLZ and Original Applicant = Philips Medical Systems Nederland BV
510(K)s with Product Code = LLZ and Original Applicant = PHILIPS MEDICAL SYSTEMS NETHERLAND, B.V.
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