PlainRecordsFDA · Medical device recall
Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D and 1 more product
- Date
- July 24, 2019
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Terminated
- Filed by
- GE Healthcare, LLC
- Reason
- Potential for a transducer mis-alignment in certain transvaginal probes.
- Distribution pattern
- Distribution in the US to Texas. International distribution to France, Greece and Switzerland.
2 products in this recall
Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D
- Product
- Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D
- Quantity
- 3 devices
- Codes and lots
- Model KTZ303987-R - Serial Number (UDI Number): 226914KR0 (01008406821084301118032721226914KR0), 198026KR7 (Not Available), 220616KR7 (01008406821084301117091521220616KR7), 205375KR9 (01008406821085531116071121205375KR9)
- Recall started
- July 2, 2019
- Device type
- System, Imaging, Pulsed Doppler, Ultrasonic
- Root cause (FDA)
- Device Design
- What the company told customers
- GE Healthcare notified customers on about 07/02/2019 via "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were informed that they could continue to use the affected probes, but prior to performing a biopsy, customers should make sure they follow the instructions for safe use in the Basic User Manual to ensure proper device alignment, specifically including the biopsy, biopsy safety and biopsy setup sections. GE Healthcare will correct all affected devices at no cost and a GE Healthcare representative will contact customers to arrange for the correction. Customers were also instructed to complete and return the Medical Device Notification Acknowledgement Response form. Questions or concerns regarding the notification can be directed to GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
- Recall number
- Z-1964-2019
Repair RIC5-9A-RS System…
- Product
- Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D
- Quantity
- 2 devices
- Codes and lots
- Model H48701EJ; Serial Number 205375KR9; (UDI Number) 01008406821085531116071121205375KR9. Model KTZ157043-R Serial Number 152323KR2 (UDI Number Not Available)
- Recall started
- July 2, 2019
- Device type
- System, Imaging, Pulsed Doppler, Ultrasonic
- Root cause (FDA)
- Device Design
- What the company told customers
- GE Healthcare notified customers on about 07/02/2019 via "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were informed that they could continue to use the affected probes, but prior to performing a biopsy, customers should make sure they follow the instructions for safe use in the Basic User Manual to ensure proper device alignment, specifically including the biopsy, biopsy safety and biopsy setup sections. GE Healthcare will correct all affected devices at no cost and a GE Healthcare representative will contact customers to arrange for the correction. Customers were also instructed to complete and return the Medical Device Notification Acknowledgement Response form. Questions or concerns regarding the notification can be directed to GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
- Recall number
- Z-1965-2019
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-1964-2019, Z-1965-2019. The agency record governs; check it and the company before acting.