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U.S. Department of Health and Human Services

Class 2 Device Recall Easy Access

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  Class 2 Device Recall Easy Access see related information
Date Initiated by Firm February 16, 2005
Date Posted April 08, 2005
Recall Status1 Terminated 3 on February 13, 2006
Recall Number Z-0695-05
Recall Event ID 31233
510(K)Number K983447  
Product Classification Device, Digital Image Storage, Radiological - Product Code LMB
Product Easy Access Image Management System with CL.Net.
Code Information Part Numbers: SW R9.2 for Easy Access Enterprise Edition (W2K); R9.2, R8.2 for Easy Access Enterprise (HPUX 11); Easy Access entry R8.2 and R9.2; R2.1 and R3.1 for EasyAccess Modality  The firm utilizes site numbers instead of serial numbers. Site numbers include: 530649, 505274, 506461, 505267, 87076, 101168, 101378, 101590, 102520, 103216, 103220, 103224, 103513, 103767, 104599, 104653, 104679, 104751, 104849, 105106, 105374, 105419, 105517, 105592, 105765, 105826, 105931, 250195, 504436, 504984, 505001, 505025, 505065, 505070, 505183, 505390, 505427, 505506, 505609, 505674, 505778, 505829, 505897, 505973, 506046, 506259, 506330, 506367, 506413, 506453, 506454, 506472, 506699, 519629, 519703, 519977, 520441, 521847, 522273, 526142, 526150, 526153, 526186, 530629 
Recalling Firm/
Manufacturer		 Philips Medical Systems Sales & Service Region No. America
22100 Bothell Everett Hwy
Bothell WA 98021
For Additional Information Contact Sarah Baxter
425-487-7665
Manufacturer Reason
for Recall		 Failure to update correctly when re-transmitting an image from the modality.
FDA Determined
Cause 2		 Other
Action The firm mailed a letter on January 31, 2005, certified return receipt to their customers advising that a service representative will visit each site and install new software.
Quantity in Commerce 60
Distribution Devices distributed to hospitals and medical centers located throughout the U.S.
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 = LMB and Original Applicant = SECTRA-IMTEC AB
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