Events

Recall of Device Recall Symbia S Series SPECT System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    51483
  • Event Risk Class
    Class 2
  • Event Number
    Z-1648-2009
  • Event Initiated Date
    2009-03-11
  • Event Date Posted
    2009-07-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80492
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Single-Photon Emission Computed Tomography - Product Code KPS
  • Reason
    Patient injury can occur when the patient is lying on the patient bed and the automatic collimator exchanger is undergoing a collimator change operation at the launch of an acquisition workflow. detector motions required for this change can cause collision with the patient or pallet if it is in brain scan position, i.E. the patient or pallet is into the field of view.
  • Action
    Siemens sent Urgent Field Correction Recall letters dated 1/20/09 to all users of the Symbia S and Symbia T Systems. The accounts were informed of the potential injury to patients while lying on the patient bed and the automatic collimator exchanger is undergoing a collimator change operation at the launch of an acquisition workflow. The customers were advised to perform all necessary collimator changes before the patient is positioned on the patient bed, and to examine each of their workflows that include a Tomo Acquisition activity and make sure the Auto Collimator Change check box on the Camera Parameters Tab is not checked. They also were advised that a Siemens Customer Service Representative would contact them within 60 days to schedule a corrective software upgrade free of charge. Any questions were directed to contact Siemens Medical Solutions USA, Inc. at 1-800-767-2313 (USA) for assistance. The accounts were requested to complete the Mandatory Fax-Back Form acknowledging receipt and understanding of the letter.

Device

Device Recall Symbia S Series SPECT System
  • Model / Serial
    Part number 8717741, serial numbers 1001, 1002, 1003, 1005, 1006, 1014, 1052, 1066, 1070, 1073, 1074, 1081, 1085, 1108, 1109, 1110, 1112, 1113, 1117, 1118, 1119, 1120, 1123, 1124, 1126, 1128, 1129, 1131, 1132, 1137, 1138, 1142, 1144, 1148, 1159, 1161, 1162, 1163, 1167, 1171, 1172, 1173, 1174, 1176, 1177, 1179, 1180, 1183, 1186, 1187, 1189, 1192, 1196, 1197, 1198, 1200, 1201, 1203, 1204, 1205, 1206, 1207, 1211, 1212, 1214, 1215, 1216, 1217, 1218, 1223, 1224, 1225, 1227, 1229, 1230, 1231, 1236, 1239, 1240, 1241, 1242, 1243, 1244, 1245, 1246, 1248, 1249, 1252, 1253, 1254, 1257, 1258, 1259, 1262, 1263, 1264, 1266, 1267, 1268, 1270, 1271, 1272, 1274, 1276, 1281, 1282, 1285, 1287, 1288, 1291, 1292, 1293, 1295, 1296, 1298, 1299, 1300, 1301, 1302, 1303, 1304, 1305, 1306, 1308, 1309, 1310, 1311, 1312, 1313, 1314, 1316, 1318, 1319, 1322, 1323, 1327, 1328, 1329, 1332, 1334, 1336, 1337, 1340, 1341, 1343, 1346, 1347, 1348, 1349, 1350, 1351, and 1352
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution, including USA, Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Ireland, Italy, Japan, Korea, Kuwait, Netherlands, Norway, Poland, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Sweden and Switzerland.
  • Product Description
    Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Part number 8717741.
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc., 2501 Barrington Rd, Hoffman Estates IL 60195-2061
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA