EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radiographic images.
Enforcement
- Recall Number
- Z-0279-2024
- Event ID
- 93200
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Philips North America Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 15, 2023
- Initiation Date
- September 21, 2023
- Classification Date
- November 8, 2023
- Address
- 222 Jacobs St, Cambridge, MA, 02141-2289, United States
Description
EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radiographic images.
Potential for units suspended on the ceiling to fail and fall.
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.
Nationwide distribution.
40 units