Recall Z-1053-2019— Philips North America, LLC
Class II · Terminated
Class II FDA medical device recall by Philips North America, LLC, initiated 2019-02-28, terminated 2020-08-03. It names one FDA 510(k) clearance: K911098. Product: 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: 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..
- Recalling firm
- Philips North America, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-02-28
- Terminated
- 2020-08-03
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.