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Class 2 Device Recall Philips |
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Date Initiated by Firm |
September 21, 2006 |
Date Posted |
November 16, 2006 |
Recall Status1 |
Terminated 3 on August 11, 2020 |
Recall Number |
Z-0184-2007 |
Recall Event ID |
36489 |
510(K)Number |
K033715
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Product Classification |
physiological monitoring system - Product Code DQA
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Product |
M1020B PulseOximetry Module Philips FAST Sp02 and Pulse Oximetry Nellcor OxiMax Compatible used with the IntelliVue or M3/M4 patient monitor M1002 |
Code Information |
M1020B #AO01 AND #A02 with S/N DE524xxxxx M102B #A01 and #A02 with S/N DE612xxxxx With Sp02 Firmware (Fw) Rev: Sp02 DSP Fw-Rev. A.01.42 |
Recalling Firm/ Manufacturer |
Philips Medical Systems 3000 Minuteman Road Andover MA 01810-1032
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For Additional Information Contact |
Michael Moriarty 978-659-3302
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Manufacturer Reason for Recall |
Unexpected pulse oximetry (Sp02) readings (100%) over time when sensor is not attached to 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
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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 |
442 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
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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.
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510(K) Database |
510(K)s with Product Code = DQA and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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