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U.S. Department of Health and Human Services

Class 2 Device Recall Symbia

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 Class 2 Device Recall Symbiasee related information
Date Initiated by FirmMarch 11, 2022
Create DateApril 07, 2022
Recall Status1 Terminated 3 on April 14, 2023
Recall NumberZ-0893-2022
Recall Event ID 89790
510(K)NumberK200474 
Product Classification System, tomography, computed, emission - Product Code KPS
ProductSymbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
Code Information A) Symbia Intevo Bold system; Model Number 11007962; Serial Numbers: 1) 1499 (UDI:40568690011591499) 2) 1501(UDI: 40568690011591501) 3) 1505 (UDI: 40568690011591505) 4) 1510 (UDI: 40568690011591510)  B) Symbia Intevo 6 system; Model Number 10764803; Serial Numbers: 1) 2352 (UDI: 40568690012342352) 2) 2353 (UDI: 40568690012342353) 3) 2354 (UDI: 40568690012342354) 
FEI Number 1000514697
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
2501 Barrington Rd
Hoffman Estates IL 60192-2061
For Additional Information ContactLaura Meyer
847-217-2734
Manufacturer Reason
for Recall		There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionCustomer Advisory Notice Letter will be provided to each impacted consignee. Depending on the customer s capabilities, Siemens provides the letters via mail, e-mail, or hand delivery by a service engineer. The receipt of the letter will be documented, and additional attempts will be made until such receipt is acknowledged. The safety advisory letter informs customers: You may continue to use your system ensuring to follow all instructions in the Operator Manual. If any changes in system vibrations or noises are detected, then activate the Emergency Stop (E-Stop), discontinue use of the system immediately and contact your service engineer.
Quantity in Commerce7 devices
DistributionDistribution OUS only to El Salvador, France, Germany, Japan, Taiwan, and UK.
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = KPS
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