Reported Jul 4, 2018 · Terminated
Ingenuity Core128 728323
Philips Medical Systems (Cleveland) Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems (Cleveland) Inc · 595 Miner Rd · Cleveland, OH · 44143-2131
Is this the product you have?
- Ingenuity Core128 728323
- Lot codes and dates
8 of 8 products
Products covered by this recall # Barcodes Product as published 1 00884838059504(01)00884838059504(21)320403, Serial Number: 320403 2 00884838059504UDI: (01)00884838059504(21)320405, Serial Number: 320405 3 00884838059504UDI: (01)00884838059504(21)320406, Serial Number: 320406 4 00884838059504UDI: (01)00884838059504(21)336321, Serial Number: 336321 5 00884838059504UDI: (01)00884838059504(21)320411, Serial Number: 320411 6 00884838059504UDI: (01)00884838059504(21)336323, Serial Number: 336323 7 00884838059504UDI: (01)00884838059504(21)320425, Serial Number: 320425 8 Serial Number: 320122 - Amount recalled
- 28 total
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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