Big Bore Oncology tomography X-ray system scanner recall
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…
Why was Big Bore Oncology tomography X-ray system scanner recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 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
- Recall date
- July 6, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)