|
Product Description
|
Recall Class
|
FDA Recall Posting Date
|
Recalling Firm
|
Z-0328-2024 - Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging,
ultrasound guided needle aspiration and other endoscopic procedures within the
airways, trancheobronchial tree, esophagus and surr...
|
2
|
11/17/2023
|
Aizu Olympus Co., Ltd.
|
Z-0327-2024 - Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
Models:
BF-1T150
BF-1T60
BF-1TH190
BF-1TQ170
BF-3C160
BF-3C40
BF-H190
BF-MP190F
BF-MP60
B...
|
2
|
11/17/2023
|
Aizu Olympus Co., Ltd.
|
Z-0330-2024 - Choleodochoscope-
Models:
CHF-BP30
CHF-CB30L
CHF-P60
|
3
|
11/17/2023
|
Aizu Olympus Co., Ltd.
|
Z-0341-2024 - Colonoscope-indicated for use within the lower digestive tract (including the anus,
rectum, sigmoid colon, colon, and ileocecal valve).
Models:
PCF-H180AI
PCF-H180AL
PCF-H190DI
PCF-H190DL
PC...
|
2
|
11/17/2023
|
Aizu Olympus Co., Ltd.
|
Z-0329-2024 - Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve).
Models:
CF-2T160I
CF-2T160L
CF-H170I
C...
|
2
|
11/17/2023
|
Aizu Olympus Co., Ltd.
|
Z-0331-2024 - Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney
Models:
CYF-5
CYF-VH
CYF-VHR
|
2
|
11/17/2023
|
Aizu Olympus Co., Ltd.
|
Z-0346-2024 - Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other
ancillary equipment for endoscopy and endoscopic surgery
Models:
TJF-145
TJF-150
TJF-Q180V
TJF-Q190V
|
2
|
11/17/2023
|
Aizu Olympus Co., Ltd.
|
Z-0334-2024 - Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
Models:
GIF-1TH190
GIF-1TQ160
GIF-2T160
GIF-2TH180
GIF-H170
G...
|
2
|
11/17/2023
|
Aizu Olympus Co., Ltd.
|
Z-0333-2024 - Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA)
and for endoscopic surgery within the upper digestive tract.
Models:
GF-UC140P-AL5
GF-UCT180
GF-UE160-AL5
|
2
|
11/17/2023
|
Aizu Olympus Co., Ltd.
|
Z-0337-2024 - Hysterofiberscope-For endoscopic diagnosis within the uterus
Models:
HYF-XP
|
2
|
11/17/2023
|
Aizu Olympus Co., Ltd.
|