Integrated Orbiter Single Detector General Purpose Gamma Camera System; Siemens Medical Systems, Inc., Nuclear Medicine
FDA device recall Z-0617-03 · posted 2003-03-06 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- Unintended yoke rotational motion.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- IYX
- Quantity affected
- 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,
- Date initiated
- 2003-02-10
- Date posted
- 2003-03-06
- Date terminated
- 2004-04-30
- Location
- Hoffman Estates, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ORBITOR II COUNTER BALANCE CAMERA (K850397) | Siemens Gammasonics, Inc. | 1985-03-26 |