| Class 2 Device Recall Hitachi Echelon MRI System |  |
Date Initiated by Firm | April 16, 2015 |
Date Posted | March 23, 2017 |
Recall Status1 |
Terminated 3 on June 29, 2017 |
Recall Number | Z-1542-2017 |
Recall Event ID |
76373 |
510(K)Number | K083533 |
Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
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Product | Hitachi Echelon MRI System |
Code Information |
V001, V002, V003, V004, V005, V006, V007, V008, V009, V010, V011, V012, V013, V014, V015, V016, V017, V018, V020, V021, V022, V023, V024, V025, V026, V027, V028, V029, V030, V031, V032, V033, V034, V035, V036, V037, V038, V039, V040, V041, V042, V043, V044, V045, V046, V047, V048, V049, V050, V051, V052, V053, V054, V055, V056, V057, V058, V059, V060, V061, V062, V063, V064, V065, V066, V067, V068, V952 |
Recalling Firm/ Manufacturer |
Hitachi Medical Systems America Inc 1959 Summit Commerce Park Twinsburg OH 44087-2371
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For Additional Information Contact | Douglas J. Thistlethwaite 330-425-1313 Ext. 3720 |
Manufacturer Reason for Recall | Image data transferred from the MRI system to a workstation showed errors on the slice position reference image. |
FDA Determined Cause 2 | Software in the Use Environment |
Action | Formal notification letters were sent to consignees on 2/13/17. Hitachi Service will update the software at each site during visits. |
Quantity in Commerce | 68 units |
Distribution | US nationwide distribution. The products were distributed to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY.
There are four (4) government accounts for this recall: VA Medical Center/Lyster Army Health Clinic, Building 301 - Andrews Avenue, Fort Rucker, AL 36362; Parma VA Medical Center, 8787 Brookpark Rd, Parma, OH 44129; Viera VA Outpatient Clinic, 2900 Veterans Way, Viera, FL 32940; Perry Point VA Medical Center, Avenue D, Suite 1A-120, Perry Point, MD 21902.
There are zero (0) Canada accounts for this recall.
There are two (2) Mexico accounts for this recall: Hospital General Tipo "B" de Alta Especialidad - SMH, "Fraccionamiento 1 De La Parcela 101, Del Ejido De Atapaneo", Morelia, MX 58300; Hospital General de Occidente, Zoquipan 1050 Avenue, Zapopan Jalisco, MX 45170
The product was distributed to the following countries: Brazil. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = LNH
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