FDA Device recall Z-1383-2023
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
- FDA Device
- Class II
- ongoing
- Published 2023-04-19
On 2023-04-19 the FDA classified a Class II recall of DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204 by Philips North America, citing 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 car….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1383-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-09 |
| Published | 2023-04-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips North America |
| Distribution | US |
Product
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
Reason
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
Identifiers
| code_info | UDI-DI: (01)00884838095199(21)210159 US: Serial Numbers: 210034 210049 210097 210182 210187 210245 220002 220006 22000…UDI-DI: (01)00884838095199(21)210159 US: Serial Numbers: 210034 210049 210097 210182 210187 210245 220002 220006 220009 220020 OUS: 200001 200002 200005 200006 200007 200009 200010 200011 200012 200013 200014 200015 200017 200018 200019 200022 200023 200024 200026 200027 200028 200029 200030 200031 200032 200033 200034 200035 200036 200037 200040 200041 200042 200044 200045 200046 200047 200048 200049 200050 200051 200052 200053 200055 200056 200058 200063 200064 200067 200068 210001 210002 210003 210004 210005 210006 210007 210008 210009 210010 210011 210012 210016 210017 210018 210019 210020 210021 210022 210023 210024 210025 210026 210027 210028 210029 210030 210031 210032 210033 210035 210036 210037 210038 210039 210056 210057 210058 210059 210060 210061 210063 210064 210065 210066 210067 210068 210070 210071 210072 210073 210074 210075 210076 210077 210078 210079 210081 210082 210083 210086 210087 210089 210090 210092 210096 210098 210100 210101 210103 210104 210105 210106 21010 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1383-2023%22
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