Recall Z-0617-03 ยท IYX Camera, Scintillation (Gamma)
Siemens Medical Solutions USA, Inc.
Integrated Orbiter Single Detector General Purpose Gamma Camera System; Siemens Medical Systems, Inc., Nuclear Medicine Group, 2501 North Barrington Road, Hoffman Estates, IL 60195-5203
| Date | Mar 6, 2003 (initiated Feb 10, 2003) |
| Status | Terminated |
| Reason | Unintended yoke rotational motion. |
| Root cause | Other |
| Action | Siemens sent Customer Advisory letters dated 2/10/03 to all Integrated Orbiter customers. The accounts were informed of the problem with unexpected camera movement in the opposite direction at the beginning of a SPECT study, and were advised to use the emergency stop at any indication of improper camera movement. The customers were advised that they would be contacted by their Siemens Customer Service Representative to schedule a firmware upgrade that will prevent the occurrence of unintended camera rotation. The upgrade will be done free of charge. |
| Quantity | 256 units |
| Distribution | Nationwide, United Arab Emirates, Argentina, Austria, Azerbaizan,Bangladesh, Belgium, Brazil, Canada, China, Colombia, Cyprus, France, Germany, Great Britain, Greece, Hong Kong, India, Ireland, Italy, Jordan, Japan, Korea, Norway, Pakistan, Romania, Switzerland, Tunisia, Venezuela and the Netherlan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K850397 | ORBITOR II COUNTER BALANCE CAMERA Siemens Gammasonics, Inc., Mar 26, 1985 |