Z-0271-2024 Class II Ongoing

Recalled by Philips North America Llc — Cambridge, MA

Recall Details

Product Type
Devices
Report Date
November 15, 2023
Initiation Date
September 21, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
46 units

Product Description

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

Reason for Recall

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

Distribution Pattern

Nationwide distribution.

Code Information

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.