Recall Z-1675-2012 ยท LNH System, Nuclear Magnetic Resonance Imaging
Siemens Medical Solutions USA, Inc
Siemens MAGNETOM Essenza, Nuclear Magnetic Resonance Imaging System Product Usage: Nuclear magnetic resonance imaging
| Date | May 25, 2012 (initiated Mar 30, 2012) |
| Status | Terminated |
| Reason | There is an error in the compatibility data sheet which is part of the System Owner Manual |
| Root cause | Error in labeling |
| Action | Siemens issued a Customer Safety Advisory Notice letter to affected customers on March 30, 2012. The letter identified the affected product, problem, potential risk and what steps can the user take to avoid the potntial risk of this issue. Siemens is releasing corrected pages of the Operator Manual in order to deliver clear guidance and recommendation for the users. Customers are instructed to ensure that the safety advisory and updated pages are replaced in the System Owner Manual. |
| Quantity | 97 |
| Distribution | US Nationwide Distribution - including the states of AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, LA, MS, MO, NE, NJ, NY, NC, OH, OR, PA, TN, TX, WA, WI, WY and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071925 | MAGNETOM ESSENZA Siemens Medical Solutions USA, Inc., Aug 14, 2007 |