Date Initiated by Firm |
May 19, 2020 |
Create Date |
June 10, 2020 |
Recall Status1 |
Terminated 3 on August 25, 2020 |
Recall Number |
Z-2337-2020 |
Recall Event ID |
85729 |
510(K)Number |
K090483
|
Product Classification |
Electrocardiograph - Product Code DPS
|
Product |
Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 is a patient monitor that measures oxygen saturation (Sp02), respiration and CO2. The user interface is designed for fast and intuitive operation. |
Code Information |
Serial Number USPP000004 |
Recalling Firm/ Manufacturer |
Philips North America, LLC 3000 Minuteman Rd Andover MA 01810-1032
|
For Additional Information Contact |
Philips Customer Services 800-722-9377
|
Manufacturer Reason for Recall |
Philips has identified a Philips SureSigns VM1 monitor in the possession of a clinical user that was not intended for commercial distribution and for which Philips does not have records regarding its manufacture. Philips is therefore removing this device from distribution.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
On May 19, 2020, the firm sent the affected customer an URGENT Medical Device Removal letter, informing them of the issue. The firm is unaware of any other pre-production VM1 devices in distribution. The customer was asked to immediately locate the affected unit, remove it from clinical use, and quarantine the device in a secure location. A Philips representative will contact the customer to arrange for the removal of the affected unit.
Customers with questions may contact their local Philips representative or call 1-800-722-9377. |
Quantity in Commerce |
1 |
Distribution |
US Nationwide distribution including in the state of NJ. |
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 = DPS and Original Applicant = PHILIPS MEDICAL SYSTEMS
|