| Date Initiated by Firm |
June 12, 2023 |
| Date Posted |
August 11, 2023 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-2397-2023 |
| Recall Event ID |
92720 |
| 510(K)Number |
K213583
|
| Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
|
| Product |
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700) |
| Code Information |
Product Number: 782120:
UDI-DI: 00884838104112;
Serial Numbers: 65041
65031
65030
65025
65023
65019
65013
65009
65008
65007
65006
65005
65004
65003
65002
65000
65020;
Product Number 782130:
UDI-DI: 00884838104402;
Serial Numbers: 45301
45298
45007
45297 |
Recalling Firm/
Manufacturer |
Philips North America
222 Jacobs St
Cambridge MA 02141-2296
|
Manufacturer Reason
for Recall |
The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by powercycling the system.
|
FDA Determined
Cause 2 |
Under Investigation by firm |
| Action |
An URGENT Medical Device Correction Notice dated 6/5/23 was sent to customers.
Actions that should be taken by the customer / user in order to prevent risks for patients or users:
4.1. Philips has installed a SmokeDetector Interlock feature on all the systems listed in Appendix A.
¿ Post this notice near the affected MR system(s) for ease of reference.
¿ Circulate this notice to all users of this device so that they are aware of the product issue
and associated hazard/harm until this issue has been resolved.
¿ Please complete and return the attached updated customer response form to Philips
promptly and no later than 30 days from receipt of this letter. Philips is requesting that
even if you acknowledged a previous version of this letter that you also respond with an
acknowledgment to this updated letter.
4.2. The SmokeDetector Interlock feature is integrated with the MR System and powers off the relevant part of the system (Gradient Amplifier) when smoke is detected in order to prevent further development of smoke and/or fire. If the SmokeDetector Interlock has detected smoke and has powered off the Gradient Amplifier:
¿ Remove patient from the system according to the instructions for use because power
to the tabletop will still be active
¿ Scanning is disabled until Philips service has checked the system. Do not attempt to
continue scanning.
¿ Immediately inform Philips Service
¿ DO NOT attempt to restart or perform a power cycle of the system
4.3. If a user experiences smoke, fire, or severe image quality issues (image artifacts caused by electrical disturbances):
¿ Immediately stop scanning and evacuate the patient from the Examination Room.
¿ Check Examination Room for a developing fire.
¿ If a developing fire is sensed, adhere to established fire emergency procedures, which
may include switching off power to the complete system and/or removing the magnet
field by using the Emergency Magnet Off button
¿ Scanning is disabled until Philips service has checked t |
| Quantity in Commerce |
601 total |
| Distribution |
US Nationwide. Global 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 = LNH and Original Applicant = Philips Medical Systems Nederland B.V.
|
