| Date Initiated by Firm | July 20, 2023 |
|---|
| Date Posted | April 21, 2025 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1583-2025 |
|---|
| Recall Event ID |
96598 |
| 510(K)Number | K183040 K212813 |
|---|
| Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
| Product | Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures. |
|---|
| Code Information |
Zenition 70 |
| FEI Number |
3000976525
|
Recalling Firm/
Manufacturer |
Philips Medical Systems Nederland B.V.
High Tech Campus 36
Eindhoven Netherlands
|
| For Additional Information Contact | Dusty Leppert, CHP
978-228-0190 |
|---|
Manufacturer Reason
for Recall | Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch. |
|---|
FDA Determined
Cause 2 | Software design |
|---|
| Action | Philips will send a customer notification to the existing users of the affected systems to alert them of the issue and provide the following actions that should be taken to prevent risks to patients:
Keep the Electronic Product Radiation Correction letter with the documentation of the
system.
Where possible, place the Wireless Foot Switch within a 3 meter range from the C-arm stand
to minimize as much as possible the potential delay of 72 milliseconds.
Circulate this Electronic Product Radiation Correction letter to all users of the system so that
they are aware of the issue.
Philips will contact customers to schedule a visit to arrange for a Field Service Engineer visit to
update the Software free of charge. (Philips reference 2024-IGT-PUN-007). |
|---|
| Quantity in Commerce | 12 systems |
|---|
| Distribution | US Nationwide distribution |
|---|
| 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 = OWB
|
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