| | Class 2 Device Recall Radiography 7000 M |  |
| Date Initiated by Firm | September 18, 2026 |
|---|
| Date Posted | October 26, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0288-2027 |
|---|
| Recall Event ID |
100074 |
| 510(K)Number | K233678 |
|---|
| Product Classification |
System, x-ray, mobile - Product Code IZL
|
| Product | Model Number: 712010. |
|---|
| Code Information |
Model Number: 712010. 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(01)00884838115521(21)24000018, (01)00884838115521(21)24000015, (01)00884838115521(21)24000013, (01)00884838115521(21)24000017, (01)00884838115521(21)24000016. |
| FEI Number |
3006648320
|
Recalling Firm/
Manufacturer |
Philips North America
222 Jacobs St
Cambridge
MA
02141-2296
|
| For Additional Information Contact | Customer Care Solution Center
800-722-9377 |
|---|
Manufacturer Reason
for Recall | Potential for the device to fail immediately after an exposure, causing the system to remain stationary. |
|---|
FDA Determined
Cause 2 | Software design |
|---|
| Action | Philips Medical Systems notified consignees on about 09/18/2026 via "URGENT Medical Device Correction" letter. Consignees were instructed that they may continue to use the affected system in accordance with its intended use, however if the no-drive issue occurs and prevents repositioning of the system, system movement may be restored through one or more of the following options:
- Option 1: System reboot:
Power OFF the unit, wait at least 10 seconds, and then power system ON
While system startup may take up to 4 minutes, drive functionality will be
available within approximately 8 seconds after the unit is powered on.
Confirm that drive functionality has been restored before continuing clinical use.
- Option 2: Use alternate registered RFID card:
Use a different registered RFID card than the one most recently used to log into
the system (for example, the backup RFID card kept with the system).
Hold the RFID card over the RFID reader until an audible beep is heard (typically
within 1 to 3 seconds).
Confirm that drive functionality has been restored before continuing clinical use.
- Option 3: Manually unlock the wheels using tools provided on the system to free the
movement of the system.
Consignees were requested to circulate the notification all users of the device for their awareness, retain the notification with the system until the correction is complete and complete and return the provided response form.
Philips will be implementing a software correction to address the issue. A Philips representative will contact consignees to schedule implementation when the correction becomes available.
If you have any questions, contact the Customer Care Solution Center at 800-722-9377. |
|---|
| Quantity in Commerce | 563 units |
|---|
| Distribution | Worldwide Distribution: (US Nationwide) and International distribution to Angola, Australia, Austria, Canada, Chile, Cook Islands, Finland, France, Germany, Ghana, Gibraltar, Guadeloupe, Honduras, Israel, Italy, Latvia, Lithuania, Macedonia, Namibia, Netherlands, New Zealand, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Switzerland, United Arab Emirates, 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 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 = IZL
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