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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Medical

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  Class 2 Device Recall Philips Medical see related information
Date Initiated by Firm July 24, 2006
Date Posted September 12, 2006
Recall Status1 Terminated 3 on August 11, 2020
Recall Number Z-1487-06
Recall Event ID 35785
510(K)Number K033715  
Product Classification physiological patient monitoring system - Product Code DQA
Product IntelliVue MultiMeasurement Server (MMS)/Multimeasurement Server, physiological patient monitoring system.
Model: M3001A
Code Information M3001A options A01, A01C06, A01C12, and A01C18 with serial number prefix DE512 and MMS software revision C.0 or B.1 M3001A options A02, A02C06, and A02C18 with serial number prefix DE441 and DE512 and MMS software revision C.0 or B.1
Recalling Firm/
Manufacturer		 Philips Medical Systems
3000 Minuteman Road
Andover MA 01810-1032
For Additional Information Contact LeeAn Rogus
978-659-4252
Manufacturer Reason
for Recall		 Patient monitor may display inaccurate reading when the Disposable Sp02 Sensor is not attached
FDA Determined
Cause 2		 Other
Action Philips is using the contract services of Sterling, Indianapolis, IN to contact all consignees regarding the correction/upgrade to the device. The letter notification dated 7/21/06 was mailed UPS Delivery Tracking the week of 07/24/06. Additionally, Philips included with the Urgent Device Correction Notice a procedure to mitigate risk until the upgrade is installed.
Quantity in Commerce 48,699 units
Distribution Worldwide, including USA, Canada, Argentina, Australia, Austria, Belgium, Brazil, Czech, Croatia, China, Denmark, Finland, France, Germany, Israel, Italy, Jordan, Kuwait, Luxemburg, Netherlands, Oman, Norway, Poland, Portugual, Poland, Russia, South Africa, Spain, Sweden, Swizerland, Turkey, UAE, Yemen, UK, Zimbabwe, Zambia, India, Indonesia, Japan, Korea, Philipines, Malaysia, Singapore, Sri Lanka, Taiwan, Vietnam, Venezuela.
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 = DQA and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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