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U.S. Department of Health and Human Services

Class 2 Device Recall BrightView SPECT

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  Class 2 Device Recall BrightView SPECT see related information
Date Initiated by Firm June 10, 2019
Create Date July 22, 2019
Recall Status1 Terminated 3 on July 24, 2020
Recall Number Z-2009-2019
Recall Event ID 83201
510(K)Number K080927  
Product Classification System, tomography, computed, emission - Product Code KPS
Product BrightView SPECT, Model Number 882480
Code Information Serial Numbers: 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0186 4000038 4000077 4000320 4000387 4000152 4000235 4000242 4000043 4000137 4000267 4000198 4000499 4000271 4000589 4000221 4000037 40007050005 4000200 4000456 4000327 4000181 4000492 4000165 4000252 4000371 4000513 4000435 4000596 4000426 4000440 4000196 4000363 4000230 4000599 4000605 4000260 4000391 4000482 4000244 4000162 4000402 4000304 4000052 4000445 4000118 4000355 4000261 4000522 4000584 4000671 4000078 4000174 4000490 4000553 4000480 4000334 4000245 4000295 4000452 4000586 4000360 4000170 4000670 4000608 4000329 4000175 4000527 4000199 4000211 10422 4000515 4000393 
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Holly Wright Lee
440-483-7600
Manufacturer Reason
for Recall		 An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.
FDA Determined
Cause 2		 Under Investigation by firm
Action Urgent Field Safety Notice Medical Device Correction letters dated 6/4/19 were sent to customers. Discontinue Use of the BrightView Handcontroller. Remove the handcontroller from the charging station and store in a secure location inaccessible by technicians, at least 20 meters (65 feet) away from the system and outside the imaging room. If 20 meters (65 feet) is not possible, then store the handcontroller in an area that is shielded, such as a hot lab. Do not dispose of the hand controller, as it will be needed once a solution is identified. Instead of the physical handcontroller, use the virtual handcontroller located on the touchscreen monitor attached to the gantry as shown in Figure 3. Philips Healthcare is distributing this FSN to all affected customers/users and will deploy a technical solution addressing the issue upon completion of the investigation. If you need any further information or support concerning this issue, please contact your local Philips representative: For SUPPORT in North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, follow the prompts).
Quantity in Commerce 696
Distribution Worldwide Distribution - US Nationwide
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = KPS and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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