Recall Z-2322-2012— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2012-08-21, terminated 2014-04-03. It names one FDA 510(k) clearance: K111912. Product: Siemens Mobilett Mira. Mobile X-Ray System.. Reason: During regular product monitoring, Siemens has become aware of a potential issue with the Mobilett Mira system. During normal clinical operation the switch on the motor drive handle of the unit may become loose and slide horizontally to the right and become trapped under the cover. This may cause the system to continuously move. In response, Siemens has issued Update Instruction XP038/12/S to r.
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-08-21
- Terminated
- 2014-04-03
- Firm location
- Malvern, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Siemens Mobilett Mira. Mobile X-Ray System.
Reason for recall
During regular product monitoring, Siemens has become aware of a potential issue with the Mobilett Mira system. During normal clinical operation the switch on the motor drive handle of the unit may become loose and slide horizontally to the right and become trapped under the cover. This may cause the system to continuously move. In response, Siemens has issued Update Instruction XP038/12/S to r
Data sourced from openFDA. This site is unofficial and independent of the FDA.