Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0220-2007

Konica Minolta PrintLink III Model - ID/IV, code no. 0770, 0771 Medical Imaging Communication Device Model IV...

Konica Minolta, Inc. / initiated 2006-10-06 / Terminated

Konica Minolta Medical Imaging USA, Inc. began a recall of Konica Minolta PrintLink III Model - ID/IV, code no. 0770, 0771 Medical Imaging Communication Device Model IV - product code 5000230 Model ID, product code... on . The reason FDA records is "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". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0220-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Konica Minolta, Inc.
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
Product code
LMD System, Digital Image Communications, Radiological
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 root cause
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.
Product codes and lots
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.