ClearanceBrief
Recall Z-0220-2007 ยท LMD System, Digital Image Communications, Radiological

Konica Minolta Medical Imaging USA, Inc.

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

DateNov 28, 2006 (initiated Oct 6, 2006)
StatusTerminated
ReasonThe power supply of a unit located in Japan overheated and caused a smoke condition and a small amount of flame coming off the unit.
Root causeOther
ActionLetters 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.
Quantity91 units
DistributionNationwide to imaging centers, hospitals and clinics.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K900227MVP (MULTI-VENDOR PROTOCOL CONVERTOR)
Merge Technologies, Inc., Feb 12, 1990