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Class 2 Device Recall Vantage Titan 1.5T |
 |
| Date Initiated by Firm |
May 21, 2021 |
| Create Date |
July 09, 2021 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-2044-2021 |
| Recall Event ID |
88014 |
| 510(K)Number |
K122613
|
| Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
|
| Product |
Toshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI System, REF: MRT-1504 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA. |
| Code Information |
Affected serial numbers: U4A12Z2020,
S4D1132069,
S4A1032017,
U4B1492081,
U4B1582100,
S4A1072035,
A4A1222019,
S4D1172090,
U4A1312024,
S4A1072034,
S4A1082040,
A4A11Z2011,
U4A1282003,
U4B1442070,
U4A1352035,
U4B1552097,
U4A12X2010,
S4C1112065,
S4C1112064,
S3A0922024,
S4E1192094,
A4A11Z2009,
S3A0972032,
S4A09Y2002,
S4A09Z2006,
U4A1382047,
S4A1062031,
S3A0972030,
U4A12X2011,
S4C1112061,
U4A13X2054,
A4A1222015,
U4B1642106,
A4A1222017,
S4A10X2047,
S4A09Z2007,
U4B1522092,
A4A11X2004,
S4D1132074,
U4A1312023,
S4A1052025,
S3A0982035,
S3A08Y2014,
U4A1312022,
S4B10Y2051,
U4A1352036,
U4A1372046,
S4D1142076,
U4A1292007,
U4B1632105,
S4B10Y2052,
U4A1352037,
U4A12Z2018,
U4A1312021,
U4B1482077,
A4A11X2002,
U4B14Y2082,
U4A13X2051,
S4B10Y2050,
A4A1252024,
U4B1532094,
U4B1652107,
S3A0922023,
S4B10Z2059,
S4A09Z2008,
U4A1382049,
S4D1142078,
L3A08Z2002,
U4A12Z2014,
S3A0822001,
A4A11Z2010,
S3A0852004,
S3A0892009,
A4A11X2003,
S3A0882007,
S4D1132073,
U4A1362039,
U4B1462074,
U4B1522091,
U4A1342033,
U4A1342034,
U4A12X2009,
U4A1412059,
U4A1412063,
U4A1282004,
U4A1352038,
U4A12Y2013,
U4B14Z2086,
S4A1022016,
S3A0942027,
S4D1162084,
U4A1292006,
S4A1042023,
U4B1512089,
A4A11X2001,
U4A1342029,
S4E1192095,
U4A1362041,
U4A12Y2012,
S4A1032018,
S3A0952029,
U4A1382050,
A4A1242021,
S4A1092046,
A4A1252023,
S3A0982033,
U4B15Y2102,
S4A09Y2004,
S4D1132071,
S4D1142075,
U4A13Y2056,
S4A10X2048,
S4A1092043,
U4B1522093,
A4A1232020,
A4A11Y2007,
S4D1162087,
S4A1012010,
U4A1412061,
S3A1062029,
S4D1172088,
S3A0872005,
A4A1212013,
U4B1482076,
S4C1112063,
U4B1552098,
S4D1152080,
S4A1042021,
S4B10Z2057,
U4A1292008,
A4A1222016,
U4B1432067,
U4B1492080,
U4A1362042,
S4A1092045,
S4A1062028,
U4B1452071,
A4A1242022,
A4A1262025,
S4A1082036,
S4C1112060,
S4D1152081,
U4A12Z2019,
U4B1512090,
S4A1042024,
U4A13X2055,
S4D1132072,
A4A11X2005,
U4B15X2101,
U4B1482079,
S4A1072032,
U4A12Z2017,
S4A1022013,
U4B1612103,
S4D1132070,
S3A0872006,
U4A1322025,
U4A1382048,
S3A0892008,
U4B1612104,
S4E1182093,
U4A13X2052,
U4B1542095,
S4A1042020,
S4A1082037,
U4A12Z2015,
S3A0922025,
S3A0982034,
U4B1452072,
S4A09Z2005,
U4B1452073,
U4B1582099,
S4A1022015,
U4B14Y2084,
S3A08X2010,
S4D1162085,
S3A08Y2013,
S4A1092044,
S4B10Y2055,
A4A1222018,
A4A1222014,
S4D1172089,
U4B1432066,
U4B1442069,
U4A13Z2057,
L3A08Z2001,
S3A09X2041,
A4A11Y2008,
S4A1062030,
S3A08Y2012,
U4B1472075,
S3A0992038,
S3A0952028,
S3A09X2040,
U4A1362043,
S4A1042022,
U4B1512087,
S4D1162086,
U4A1342031,
U4A1342032,
U4A1362040,
S4B10Y2053,
S4E1182092,
S4C1112066,
S4A1082042,
U4A12Z2016,
S4A1012009,
S4A1082038,
S3A0972031,
S4B10Z2056,
U4A1282005,
U4B1512088,
S4A1052026,
S4A1012011,
U4B14Z2085,
U4A1412060,
U4A1332028,
U4A13X2053,
U4B1442068,
U4A1362045,
U4B14Y2083,
U4B1482078,
U4B1422065,
S3A0932026,
U4A1362044,
S4A1082039,
U4B1542096,
U4A1412062,
S4A1012012,
U4A1282002, U4A1342030,
S4A09Y2003
|
Recalling Firm/
Manufacturer |
Canon Medical System, USA, INC.
2441 Michelle Dr
Tustin CA 92780-7047
|
| For Additional Information Contact |
Ms. Terry Schultz
714-730-5000
|
Manufacturer Reason
for Recall |
The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.
|
FDA Determined
Cause 2 |
Under Investigation by firm |
| Action |
On May 25,2021, Canon issued a "URGENT: MEDICAL DEVICE CORRECTION" via USPS First Class Return Receipt. On June 24,2021, Canon sent an updated recall communication via USPS First Class Return Receipt to affected consignees to provide additional information. In addition to informing consignees about the recall, the firm asked consignees to take the following actions:
1. Your local Canon Service person will schedule time to replace the applicable part with a part that meets specifications. At the same time an inspection of the gantry will be performed.
2. Until such time that the modification work is provided by your service representative if any smoke or abnormal odor are observed, immediately stop using the system and contact your service representative.
3. Please share this information with all users and reviewing radiologists as well as the clinical engineering or biomedical group at your facility.
4. Please complete the attached form that is attached and return by either fax, to the toll-free number shown at the top of the form, or by via email to RAffairs@us.medical.canon. This form is a record required by FDA for verification that this notification has been received.
5. If you have any questions, please feel free to contact Terry Schultz Regulatory Affairs Manager at (800) 421-1968 or your local Canon Medical Systems service representative at (800) 521-1968. |
| Distribution |
US Nationwide distributions in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY. |
| 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database |
510(K)s with Product Code = LNH and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
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