Precision 500D The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for r
FDA device recall Z-1754-2019 · posted 2019-06-10 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
- Action taken
- On March 29, 2019, GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated March 29, 2019 to its consignees/customers. The letter described the product, problem and actions to be taken. Customers were instructed to do the following: Please follow the precautions below until the monitor feet on your unit are replaced: -The CRT monitor and suspension should be inspected and used with caution. Make sure the monitors are secured properly to the tray before each use. -Immediately stop using the system if any looseness of the monitor is noticed and contact your GE service representative. -Monitor should not be positioned directly above the patient. -Before service or preventative maintenance of the monitor is attempted, review the service and preventive maintenance procedures. Also the customer were instructed to complete and return the MEDICAL DEVICE NOTIFICATION ACKNOWLEDGEMENT RESPONSE REQUIRED form by scanning or taking a photo of the completed form e-mailing to: Recall_10927_reply_form@ge.com. F/U visits by GE Healthcare will be made to replace the plastic feet. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 825 (38 US and 787 OUS) in total
- Distribution
- Worldwide Distribution: US (nationwide) to states of: AL, CA, CT, FL, GA, HI, IL, LA, MD, MI, MN, MO, NH, NY, OK, PA, TN, and VA; and countries of: Algeria, Argentina, Belgium, Bosnia & Herzegovina, B
- Date initiated
- 2019-03-29
- Date posted
- 2019-06-10
- Date terminated
- 2021-04-15
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRECISION 500D R&F X-RAY SYSTEM (K081091) | GE Healthcare | 2008-06-11 |
| EXPEDIO 500D R&F X-RAY SYSTEM (K011624) | GE Medical Systems | 2001-06-08 |