FDAClass IINovember 15, 2023

CombiDiagnost R90 recall

CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system

Why was CombiDiagnost R90 recalled?

Potential for units suspended on the ceiling to fail and fall.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

Model No. 709030 and 709031; UDI: (01)00884838076747(21) SN17000014 , (01)00884838076747(21) 10000020 , (01)00884838076747(21) SN17000130 , (01)00884838076747(21) SN17000123 , (01)00884838076747(21) SN18000021 , (01)00884838076747(21) SN18000001 , (01)00884838076747(21) SN18000075 , (01)00884838076747(21) SN18000002 , (01)00884838076747(21) 10000004 , (01)00884838076747(21) SN17000144 , (01)00884838076747(21) SN17000140 , (01)00884838076747(21) SN18000003 , (01)00884838076747(21) SN18000063 , (01)00884838076747(21) SN18000018 , (01)00884838076747(21) SN18000022 , (01)00884838076747(21) SN18000041 , (01)00884838076747(21) SN18000031 , (01)00884838076747(21) 10001097 , (01)00884838076747(21) 10000056 , (01)00884838076747(21) 28 , (01)00884838076747(21) 10000184 , (01)00884838076747(21) SN19000018 , (01)00884838076747(21) SN19000006 , (01)00884838076747(21) SN19000040 , (01)00884838076747(21) SN19000001 , (01)00884838076747(21) SN19000041 , (01)00884838076747(21) 10000051 , (01)00884838076747(21) 10000000 , (01)00884838076747(21) 10000087 , (01)00884838076747(21) 10001095 , (01)00884838076747(21) 10000122 , (01)00884838076747(21) 10001001 , (01)00884838076747(21) 10000145 , (01)00884838076747(21) 10000152 , (01)00884838076747(21) 10000190 , (01)00884838076747(21) 10001076 , (01)00884838076747(21) SN17000153 , (01)00884838101456(21) 10001054 , (01)00884838101456(21) 10001087 , (01)00884838101456(21) 10001086 , (01)00884838101456(21) 10001159 , (01)00884838101456(21) 10001109 , (01)00884838101456(21) 10001114 , (01)00884838101456(21) 10001171 , (01)00884838101456(21) 10001194 , (01)00884838101456(21) 10001193; Serial No. SN17000014, 10000020, SN17000130, SN17000123, SN18000021, SN18000001, SN18000075, SN18000002, 10000004, SN17000144, SN17000140, SN18000003, SN18000063, SN18000018, SN18000022, SN18000041, SN18000031, 10001097, 10000056, 28, 10000184, SN19000018, SN19000006, SN19000040, SN19000001, SN19000041, 10000051, 10000000, 10000087, 10001095, 10000122, 10001001, 10000145, 10000152, 10000190, 10001076, SN17000153, 10001054, 10001087, 10001086, 10001159, 10001109, 10001114, 10001171, 10001194, 10001193.

Product
CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system
Recalling firm
Philips North America Llc
Quantity
46 units
Distribution
Nationwide distribution.
Recall date
November 15, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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