Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Sele
FDA device recall Z-1097-2013 · posted 2013-04-11 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Siemens has become aware of a potential malfunction and possible hazard to patients and staff when using the Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select. This malfunction is possible in cases where the table vertical lift movement is obstructed by a solid object which could potentially result in collision. This can re
- Action taken
- Siemens sent a Customer Safety Advisory letter dated January 15th, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The SIEMENS service representative will investigate if parts need to be exchanged in your product, an if so, which parts need to be exchanged to restore the system safety and function. Please kindly confirm receipt of the Field Safety Notice by sending back the attached form. For further questions please call (610) 448-3237.
- Root cause
- Process design
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 51
- Distribution
- Nationwide Distribution including the states of CA, FL, GA, IA, IN, KS, LA, ME, MI, MO, NC, NH, NJ, NY, NV, OH, PA, TN, TX, VA and WA.
- Date initiated
- 2013-01-15
- Date posted
- 2013-04-11
- Date terminated
- 2013-04-23
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| URF DIGITAL - OT (K992660) | Siemens Medical Solutions USA, Inc. | 1999-11-05 |