| Date Initiated by Firm |
November 12, 2021 |
| Create Date |
January 10, 2022 |
| Recall Status1 |
Terminated 3 on February 05, 2024 |
| Recall Number |
Z-0471-2022 |
| Recall Event ID |
89174 |
| 510(K)Number |
K181830
|
| Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
| Product |
Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue
Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 722224
|
| Code Information |
US:
Model 722068 Azurion 7 B20 S/N: 109 UDI: (01)00884838085367(21)109.
OUS:
Model: S/N UDI:
722226 Azurion 7 B20 176 (01)00884838099272(21)176;
722228 Azurion 5 M20 3 (01)00884838099234(21)3;
722221 Azurion 3 M12 8 (01)00884838099203(21)8;
722225 Azurion 7 B12 16 (01)00884838099265(21)16;
722225 Azurion 7 B12 73 (01)00884838099265(21)73;
722226 Azurion 7 B20 42 (01)00884838099272(21)42;
722226 Azurion 7 B20 157 (01)00884838099272(21)157;
722224 Azurion 7 M20 293 (01)00884838099258(21)293;
722078 Azurion 7 M12 220 (01)00884838085251(21)220
|
Recalling Firm/
Manufacturer |
Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
|
Manufacturer Reason
for Recall |
(1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; (2) Emergency stop recovery problem-warm restart is not executed correctly and movement functionality is not available
|
FDA Determined
Cause 2 |
Software design |
| Action |
Philips issued Field Safety Notice on 11/12/21 U.S.A, Customer notified via certified mailing from the United States Postal Service (USPS). Letters outside of the U.S.A. will be distributed through the Philips Markets Organization.
Letter states reason for recall, health risk and action to take:
Start-up problem:
If the start-up problem occurs, perform a Cold Restart* of the system.
b) Emergency stop recovery problem:
If the emergency stop recovery problem occurs, perform a new Warm Restart* of the system.
c) Place this Field Safety Notice with the documentation of the system until Philips has installed a software update in your system.
d) Circulate this notice to all users of this device so they are aware of the product issues.
e) Return the attached reply form to Philips to confirm that the users of the system have reviewed and understood this Field Safety Notice.
* The system restart options are described in section 4.2 of the Instructions for Use.
5. Describe the actions planned by Philips IGT Systems to correct these problems:
These problems will be resolved by a software update (available in November 2021). You will be contacted by your local Philips representative to schedule the update of your system.
If you need any further information, please contact your local Philips representative (reference to FC072200502).
|
| Quantity in Commerce |
10 units (1 US and 9 OUS) |
| Distribution |
Worldwide distribution - US Nationwide distribution in the state of WA and the countries of
France, Germany, Japan, Poland, United Kingdom.
|
| 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = OWB and Original Applicant = Philips Medical Systems Nederland BV
|
