| Date Initiated by Firm | July 09, 2019 |
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| Create Date | August 22, 2019 |
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| Recall Status1 |
Terminated 3 on April 23, 2020 |
| Recall Number | Z-2344-2019 |
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| Recall Event ID |
83415 |
| 510(K)Number | K121160 |
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| Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
|
| Product | MAGNETOM Spectra magnetic resonance diagnostic devices
Model # 10837643 |
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| Code Information |
Serial # 72030 72023 |
Recalling Firm/
Manufacturer |
Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
|
| For Additional Information Contact | Meredith Adams
610-219-4834 |
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Manufacturer Reason
for Recall | Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly. |
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FDA Determined
Cause 2 | Device Design |
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| Action | 1. review the System Owner Manual chapter 1.3.3 Quench emergency plan and the section regarding defective vent line .
2. follow the standard emergency procedures you have in place in the event of system failures.
3.A Siemens Service Technician will conduct an inspection to verify that your system has a vertical outlet. If a vertical outlet is present, no further action is required. In the event your system is equipped with a horizontal outlet, the Siemens Service Technician will ensure that the port for the drop-off plate is adequately blanked off or sealed.
4.service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436.
5. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Customer Safety Advisory Notice. By signing this document you are acknowledging that you have read and understand the content therein.
If you have any question, please contact Meredith Adams, Telephone
610-448-6461 and E-Mail: Meredith.adams@siemens-healthineers.com |
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| Quantity in Commerce | 2 |
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| Distribution | AL
AR
AZ
CA
CO
CT
DC
DE
FL
GA
GU
IA
ID
IL
IN
KS
KY
LA
MA
MD
ME
MI
MN
MO
MT
NC
NE
NH
NJ
NY
OH
OK
OR
PA
SC
TN
TX
VA
WA
WI
WV
WY |
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| Total Product Life Cycle | TPLC Device Report |
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|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = LNH
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