Medical Device Recall: Z-0271-2024

FDA Recalls dataset · Firm: Philips North America Llc · Status: Open, Classified

Recall Action Class: N/A Date Initiated: 2023-09-21 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0271-2024.

Recall Res Number
Z-0271-2024
Recalling Firm / Manufacturer
FEI Number
3016618143
Recall Status
Open, Classified
Recall Classification
N/A
Date Initiated
2023-09-21
Date Posted
2023-11-08
Date Terminated
N/A
Product Code
JAA
Event Number
93200
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.

Action Details The firm distributed recall notifications dated 8/31/2023 via FedEx to affected consignees. Consignees are instructed to immediately stop use of affected devices and contact their local Philips service representative if the Ceiling Suspension becomes unstable, if moving the Ceiling Suspended X-Ray Tube requires a high amount of force, or if moving the Ceiling Suspended X-Ray Tube is noticeably hampered. The recall notice is to be circulated among all device users, so they are aware of this issue and placed as an addendum in the IFU. Consignees are to complete the provided response form and return it to Philips no later than 30 days from notification receipt via email to pd.cnr@philips.com. Philips will contact consignees to schedule a time for a Field Service Engineer to visit customer sites to inspect affected systems and correct the issue. Consignees with any questions are to contact the Customer Care Solutions Center at 1-800-722-9377.

Distribution Pattern Nationwide distribution.

Code Information / Serial Numbers 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.

Related Establishments / Registrations

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