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U.S. Department of Health and Human Services

Class 2 Device Recall Philips

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  Class 2 Device Recall Philips see related information
Date Initiated by Firm October 22, 2008
Date Posted January 13, 2009
Recall Status1 Terminated 3 on March 24, 2017
Recall Number Z-0817-2009
Recall Event ID 50088
510(K)Number k082633  
Product Classification Table Mount - Product Code DSI
Product Philips M8000-64100 Table Mount

Shipped standard with all IntelliVue Patient Monitors MP40-70, Gas Modules Gl and G5 and certain options of the IntelliVue Patient Monitors MP5 MPST and MP20/30.

Product shipped between 6/03/08 and 9/12/08 as follows:
M1013A IntelliVue G1 Gas Module
M1019A IntelliVue GS Gas Module
M8001A option E22 Quick release mount for IntelliVue MP20
M8002A option E22 Quick release mount for IntelliVue MP30
M8003A IntelliVue MP40
M8004A IntelliVue MPSO
M8005A IntelliVue MP60
M8007A IntelliVue MP70
M8105A option E22 IntelliVue MP5 Quick Release Mount
M8105AT option E22 IntelliVue MPST Quick Release Mount
M8040A option U02 U02 Table top mount kit
M8040A option E22 Quick release kit for MP20MP30

The Philips IntelliVue Patient Monitors are intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP2, X2, MP5, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments.

Code Information Product shipped between 6/03/08 and 9/12/08 as follows: M1013A IntelliVue G1 Gas Module M1019A IntelliVue GS Gas Module M8001A option E22 Quick release mount for IntelliVue MP20 M8002A option E22 Quick release mount for IntelliVue MP30 M8003A IntelliVue MP40 M8004A IntelliVue MPSO M8005A IntelliVue MP60 M8007A IntelliVue MP70 M8105A option E22 IntelliVue MP5 Quick Release Mount M8105AT option E22 IntelliVue MPST Quick Release Mount M8040A option U02 U02 Table top mount kit  M8040A option E22 Quick release kit for MP20MP30  A list of S/N's can be obtained fromthe recalling firm. 
Recalling Firm/
Manufacturer		 Philips Medical Systems
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact
978-687-1501
Manufacturer Reason
for Recall		 Table Mounts assembled with incorrect length hardware may fall
FDA Determined
Cause 2		 Process control
Action Philips issued an "Urgent Medical Device Correction" notification to all potentially affected customers on 10/22/08 via UPS for the US customers. The letter mailed to customers outside the US by Philips' regulatory contacts in each country via a tracked method. The letter informs customers of the problem and gives instructions on how to identify affected table mounts. Field Service Engineers will be dispatched to each customer site to inspect each Table Mount. If customers detect any sign of a loose connection between the monitor and the mounting plate while they are awaiting the Field Service Engineer, they are instructed to make sure that the monitor is not in a position to fall. They are asked to disconnect the monitor from the table mount. For additional information, contact Philips Medical Systems at 1-978-687-1501.
Quantity in Commerce 14,292 units
Distribution Nationwide Canada Foreign: Argentina, Aruba, Australia, Austria, Bahain, Bangladesh, Belgium, Bosnia, Brazil, Chile, China, Colombia, Czech Republic, Denmark, Estonia, Egypt, Finland, France, Gabon, Germany, Great Britain, Greece, Hong Kong, Iceland, India, Iraq, Ireland , Italy, Japan, Korea, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Namibia, Netherlands, Norway, Peru, Philippines, Poland,Portugal, Russia, Saudia Arabia, Singapore, Slovenia South Africa, Spain.,. Srilinka, Sweden, Switzerland, Thailand, Tunisia, Turkey, Uganda, UAE, Uzbekistan, Venezuela, Vietnam, and Zambia
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 = DSI and Original Applicant = PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
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