Device product

EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radiographic images.

Z-0279-2024

September 21, 2023

Class II

Product summary

Firm: Philips North America Llc
Event: Event 93200
Status: Ongoing
Classification: Class II
Quantity: 40 units
Official record key: device-enforcement:Z-0279-2024

Official wording

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

Code information: Model No. 706050; UDI: (01)00884838074255(21) SN17000007 , (01)00884838074255(21) SN16000025 , (01)00884838074255(21) SN15000051 , (01)00884838074255(21) SN15000049 , (01)00884838074255(21) SN15000056 , (01)00884838074255(21) SN15000055 , (01)00884838074255(21) SN16000046 , (01)00884838074255(21) SN16000041 , (01)00884838074255(21) SN16000011 , (01)00884838074255(21) SN16000029 , (01)00884838074255(21) SN16000024 , (01)00884838074255(21) SN16000028 , (01)00884838074255(21) SN16000042 , (01)00884838074255(21) SN16000030 , (01)00884838074255(21) SN16000044 , (01)00884838074255(21) SN16000051 , (01)00884838074255(21) SN17000001 , (01)00884838074255(21) SN16000049 , (01)00884838074255(21) SN16000043 , (01)00884838074255(21) SN16000061 , (01)00884838074255(21) SN17000003 , (01)00884838074255(21) SN16000052 , (01)00884838074255(21) SN16000056 , (01)00884838074255(21) SN17000011 , (01)00884838074255(21) SN17000002 , (01)00884838074255(21) SN17000025 , (01)00884838074255(21) SN17000006 , (01)00884838074255(21) SN17000031 , (01)00884838074255(21) SN17000028 , (01)00884838074255(21) SN17000038 , (01)00884838074255(21) SN17000022 , (01)00884838074255(21) SN18000009 , (01)00884838074255(21) SN17000035 , (01)00884838074255(21) SN17000027 , (01)00884838074255(21) SN17000026 , (01)00884838074255(21) SN18000004 , (01)00884838074255(21) SN18000008 , (01)00884838074255(21) SN18000002 , (01)00884838074255(21) SN18000001 , (01)00884838074255(21) SN15000014; Serial No. SN17000007, SN16000025, SN15000051, SN15000049, SN15000056, SN15000055, SN16000046, SN16000041, SN16000011, SN16000029, SN16000024, SN16000028, SN16000042, SN16000030, SN16000044, SN16000051, SN17000001, SN16000049, SN16000043, SN16000061, SN17000003, SN16000052, SN16000056, SN17000011, SN17000002, SN17000025, SN17000006, SN17000031, SN17000028, SN17000038, SN17000022, SN18000009, SN17000035, SN17000027, SN17000026, SN18000004, SN18000008, SN18000002, SN18000001, SN15000014.

Distribution pattern: Nationwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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