Z-1053-2019 Class II Terminated
FDA device recall Z-1053-2019 was initiated by Philips North America, LLC on February 28, 2019 and is designated Class II. Reason for recall: The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user. The recall status is terminated (terminated August 3, 2020). Affected quantity: 1969.
Recall Details
- Product Type
- Devices
- Report Date
- April 3, 2019
- Initiation Date
- February 28, 2019
- Termination Date
- August 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1969
Product Description
Urodiagnost, Product No. 708033 Product Usage: The Philips UroDiagnost MRF can be used to perform all urological and gynecological routine examinations including: Urograms with injection or infusion Retrograde pyelography Cystography and urethrography Micturition cystography Cystoscopy, endopscopy Transurethral resection Percutaneous nephroscopy Urethrorenoscopy Percutaneous nephrolithotomy Serial angiography with image intensifier and DSI Tomography
Reason for Recall
The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
Distribution Pattern
US Nationwide domestic distribution, and worldwide international distribution.
Code Information
Serial codes 1 2 3 4 5 7 8 11 13 14 15 16 17 18 21 48 59 60 64