Philips North America Llc: Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201

Hazard

If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of the telescopic carriage will unavoidably decay through normal wear and tear; as a result there is a potential that the Ceiling Suspension of the DigitalDiagnost C50 system may descend inadvertently if power to the system is interrupted, and may result in injuries to patients and users

Details from the source

Reason for recall: If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of the telescopic carriage will unavoidably decay through normal wear and tear; as a result there is a potential that the Ceiling Suspension of the DigitalDiagnost C50 system may descend inadvertently if power to the system is interrupted, and may result in injuries to patients and users Distribution: Nationwide including Puerto Rico and Virgin Islands Foreign: ARGENTINA Australia Austria Bosnia and Herzegovina Bulgaria China Colombia Cyprus Czech Republic Egypt France French Polynesia Germany Greece Hungary Indonesia Italy Jordan Kenya Latvia Lithuania Macedonia Malta Mexico Netherlands New Zealand Philippines Poland Portugal Puerto Rico Russian Federation Saudi Arabia Serbia Slovenia South Af Quantity: US: 10 units; OUS: 570 units Lot/code info: UDI-DI: (01)00884838082366(21) US: Serial Numbers: 200072 200131 200132 200143 SN170053 SN180074 SN180163 SN180181 SN180182 SN190119 OUS: 200004 200005 200006 200011 200014 200015 200031 200039 200040 200041 200043 200046 200047 200048 200050 200054 200058 200059 200060 200061 200062 200063 200064 200065 200067 200068 200069 200070 200072 200073 200074 200075 200077 200078 200079 200080 200081 200082 200083 200085 200087 200089 200090 200091 200092 200093 200095 200096 200098 200099 200100 200101 200102 200103 200104 200105 200106 200107 200108 200109 200110 200112 200113 200114 200115 200116 200117 200118 200119 200120 200121 200122 200123 200124 200125 200130 200131 200132 200133 200134 200135 200138 200141 200143 200144 200146 200147 210001 210003 210007 210008 210009 210010 210011 210013 210014 210016 SN160004 SN160005 SN160006 SN160007 SN160008 SN160009 SN160011 SN160012 SN160013 SN160014 SN160015 SN160016 SN170001 SN170002 SN170003 SN170004 SN170005 SN170007 SN170008 SN170009 SN170010 SN170014 SN170015 SN170016 SN170017 SN170018 SN170019 SN170020 SN170021 SN170022 SN170023 SN170024 SN170025 SN170028 SN170029 SN170030 SN170031 SN170032 SN170033 SN170034 SN170035 SN170036 SN170037 SN170038 SN170039 SN170040 SN170041 SN170042 SN170043 SN170044 SN170045 SN170046 SN170048 SN170049 SN170050 SN170052 SN170054 SN170055 SN170056 SN170057 SN170058 SN170060 SN170061 SN170062 SN170063 SN170066 SN170067 SN170068 SN170069 SN170070 SN170071 SN170072 SN170073 SN170075 SN170076 SN170078

UPC codes

00884838082366

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.