Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Philips

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Philips see related information
Date Initiated by Firm September 21, 2006
Date Posted November 16, 2006
Recall Status1 Terminated 3 on August 11, 2020
Recall Number Z-0183-2007
Recall Event ID 36489
510(K)Number K033715  
Product Classification physiological monitoring system - Product Code DQA
Product M3001A Philips Multi Measurement Server (MMS)
Code Information HW Revision B: M3001 A #AO1 with S/N DE512xxxx M3001A #A02 with S/N DE512xxxx HW Revision C M3001A #A01 and #A02 with S/N DE610xxxx  With Sp)2 Firmware (Fw) Rev.: Sp02 DSP FW-Rev: A.01.41 or A.01.42
Recalling Firm/
Manufacturer		 Philips Medical Systems
3000 Minuteman Road
Andover MA 01810-1032
For Additional Information Contact Michael Moriarty
978-659-3302
Manufacturer Reason
for Recall		 Unexpected pulse oximetry (Sp02) readings (100%) over time when a sensor is not attached to the patient. In addition, with a sensor attached to a patient, an incorrect high Sp02 may be displayed when a pulse rate is in a range of 185BPM
FDA Determined
Cause 2		 Other
Action Philips issued a Customer Letter and Urgent Device Correction letter to consignees on 09/21/06. Users were notified of the problem and provided with Instructions to Mitigate Risk. A software upgrade to: version D.00.61 and Sp02 FW A.01.46 is mandatory.
Quantity in Commerce 69696 units
Distribution Worldwide, including USA, Canada, Australia, China, Hong Kong, India, Indonesia, Japan, Phillipines, Singapore, Taiwan, Thailand, Vietnam, Argentina, Brazil, Chile, Colombia, El Salvador, Jamaica, Mexico, Nicaragua. Panama, Paraguay, Peru, Venezuela, Austria, Belgium, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hungary, Germany, Israel, Italy, Jordan, Kenya, Kuwait, Lebanon, Lithuania, Luxembourg, Macedonia, Mauritania, Mauritius, Netherlands, Norway, Oman, Slovenia, South Africa, Spain, Switzerland, Turkey, UAE, UK, Yemen, Zambia, Zimbabwe
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.
-
-