FDA Device

Computed Tomography system, Diagnostic Imaging: Somatom Sensation 4 Somatom Volume Zoom Somatom Volume Access Somatom Balance Somatom Emotion Somatom Emotion Duo Somatom Esprit Somatom Esprit +

Hazard

Head holder cannot be properly secured on the table top.

What You Should Do

Remedy

Siemens sent all customers a Update Instruction CT016/02/S document alerting them to the problem. This is their recall notification.

Products

Computed Tomography system, Diagnostic Imaging: Somatom Sensation 4 Somatom Volume Zoom Somatom Volume Access Somatom Balance Somatom Emotion Somatom Emotion Duo Somatom Esprit Somatom Esprit +
Brand
Siemens Medical Systems Inc
UPC
Somatom Sensation 4 -- Serial Numbers 28001 to 28070 Somatom Volume Zoom -- Serial Numbers 24006 to 24752 Somatom Volume Access -- Serial Numbers 26111 to 26123 Somatom Valance -- Serial Numbers 38169 to 38475 Somatom Emotion -- Serial Numbers 40354 to 40383 Somatom Emotion Duo -- Serial Numbers 36081 to 36126 Somatom Esprit -- Serial Numbers 34191 to 34213 Somatom Esprit+ -- Serial Numbers 35024 to 35039

Units Affected

250