Siemens MAGNETOM Essenza, Nuclear Magnetic Resonance Imaging System Product Usage: Nuclear magnetic resonance imaging
FDA device recall Z-1675-2012 · posted 2012-05-25 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- There is an error in the compatibility data sheet which is part of the System Owner Manual
- Action taken
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 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.
- Date initiated
- 2012-03-30
- Date posted
- 2012-05-25
- Date terminated
- 2014-04-03
- Location
- Malvern, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAGNETOM ESSENZA (K071925) | Siemens Medical Solutions USA, Inc. | 2007-08-14 |