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U.S. Department of Health and Human Services

Class 2 Device Recall Big Bore Oncology

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  Class 2 Device Recall Big Bore Oncology see related information
Date Initiated by Firm June 14, 2016
Create Date June 30, 2016
Recall Status1 Terminated 3 on July 02, 2018
Recall Number Z-2109-2016
Recall Event ID 74507
510(K)Number K033357  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Big Bore Oncology tomography X-ray system scanner, model number 728243.
The Big Bore Oncology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes
Code Information Big Bore Oncology System Code 728243; Serial numbers:  75002, 75003, 75004, 75005, 75006, 75007, 75008, 75009, 75010, 75011, 75012, 75014, 75015, 75016, 75017, 75018, 75019, 75020, 75021, 75022, 75023, 75024, 75025, 75026, 75030, 75032, 75035, 75036, 75037, 75040, 75042, 75044, 75047, 75048, 75049, 75051, 75053, 75060, 75064, 75100, 75102, 75104, 75105, 750111, 750114 
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Mrs.Holly Wright Lee
440-483-2015
Manufacturer Reason
for Recall		 Socket Head Cap Screws (SHCS) used in the Z-Axis Adjustment Plate were found to be made of stainless steel rather than the specified alloy steel.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Philips Medical Systems (Cleveland), Inc. sent a Customer Information letter dated June 14, 2016, to all affected customers via certified mail. The letter identified the product, the problem, and the action to be taken by the customer. No action is required of the customer for this issue. Systems that may have been manufactured with these stainless steel fasteners still meet the safety specifications required for the adjustment cradle and may continue to be used clinically. For further information or support customers were instructed to call 1-800-722-9377. For questions regarding this recall call 404-483-2015.
Quantity in Commerce 47 units
Distribution Worldwide distribution to Belgium, China, Egypt, Germany, India, Korea, Republic of, Myanmar, Nigeria, Peru, Russian Federation, Rwanda, Singapore, Spain, Sweden, Taiwan, Thailand, and United Kingdom
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 = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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