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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 Accesssee related information
Date Initiated by FirmFebruary 16, 2005
Date PostedApril 08, 2005
Recall Status1 Terminated 3 on February 13, 2006
Recall NumberZ-0695-05
Recall Event ID 31233
510(K)NumberK983447 
Product Classification Device, Digital Image Storage, Radiological - Product Code LMB
ProductEasy 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 ContactSarah 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
ActionThe 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 Commerce60
DistributionDevices distributed to hospitals and medical centers located throughout the U.S.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LMB
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