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U.S. Department of Health and Human Services

Class 2 Device Recall Konica Minolta PrintLink III

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  Class 2 Device Recall Konica Minolta PrintLink III see related information
Date Initiated by Firm October 06, 2006
Date Posted November 28, 2006
Recall Status1 Terminated 3 on August 01, 2008
Recall Number Z-0220-2007
Recall Event ID 36658
510(K)Number K900227  
Product Classification Medical Imaging Communication Device - Product Code LMD
Product Konica Minolta PrintLink III Model - ID/IV, code no. 0770, 0771 Medical Imaging Communication Device

Model IV - product code 5000230
Model ID, product code 5000330
Konica Minolta Medical & Graphic, Inc.
No. 26-2, Nishishinjuku 1-chrome, Shinjuku-ku, Tokoyo 163-0512, Japan
Code Information Product code 0770, serial numbers: 0002, 0003, 0011, 0012, 0013, 0014, 0015, 0020, 0021, 0022, 0023, 0024, 0035, 0036, 0037, 0038, 0081, 0082, 0083, 0084, 0085, 0124, 0125, 0126, 0147, 0148, 0149, 0156, 0157, 0158, 0159, 0160.   Product code 0771, serial numbers: 0001, 0003, 0004, 0012, 0013, 0014, 0015, 0016, 0017, 0018, 0019, 0020, 0021, 0026, 0027, 0028, 0029, 0030, 0034, 0035, 0044, 0045, 0046, 0047, 0048, 0049, 0050, 0051, 0065, 0066, 0067, 0068, 0069, 0125, 0126, 0127, 0128, 0129, 0155, 0156, 0157, 0159, 0160, 0161, 0162, 0163, 0167, 0168, 0169, 0170, 0234, 0235, 0236, 0241, 0242, 0243, 0244, 0245.
Recalling Firm/
Manufacturer		 Konica Minolta Medical Imaging USA, Inc.
411 Newark Pompton Tpke
Wayne NJ 07470-6657
For Additional Information Contact Steve Eisner
800-934-1034
Manufacturer Reason
for Recall		 The power supply of a unit located in Japan overheated and caused a smoke condition and a small amount of flame coming off the unit.
FDA Determined
Cause 2		 Other
Action Letters were sent to all customers by first class US mail, certified receipt requested on 10/10/2006. Customers were also notified by fax and e-mail and a phone call on the same day.
Quantity in Commerce 91 units
Distribution Nationwide to imaging centers, hospitals and clinics.
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 = LMD and Original Applicant = MERGE TECHNOLOGIES, INC.
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