S4-1 Lumify transducer probes recalled to define transducer useful life
S4-1 Lumify Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: Rubric level 1 covers documentation issues; this is a labelling clarification with no product defect described, which the FDA classed as Class III.
Plain-English summary
The S4-1 Lumify Transducer Probe is being recalled under model numbers 989605458222, 989605477101 and 989605458221, with UDI numbers listed in the recall notice. The recall covers 171,322 units distributed nationwide in the United States.
The action was taken to provide clarification and labelling to define the useful life of ultrasound transducers in the field. The FDA classified the action as Class III. The notice does not describe a defect in the probes.
Imaging sites should follow the manufacturer's instructions for applying the updated labelling information.
The recalled product
- Product
- S4-1 Lumify Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Category
- Medical Device — Ultrasound
- Hazard
- labelling-update
- useful-life
- class-iii
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model No.989605458222
- 989605477101
- 989605458221
- UDI: (01)00884838085183(21)B3G9Q2
- (01)00884838074231(21)B1RCZ0
- (01)00884838074231(21)B1RD8W
- (01)00884838074231(21)B1RDD9
- (01)00884838074231(21)B1W89Q
- (01)00884838074231(21)B1W8D2
- (01)00884838085183(21)B2D2YM
- (01)00884838074231(21)B21YB6
- (01)00884838085183(21)B35Y6X
- (01)00884838085183(21)B36B15
- (01)00884838085183(21)B36B6J
- (01)00884838086579(21)B2C7BV
- (01)00884838085183(21)F0BH9V
- (01)00884838085183(21)F0DDFJ
- (01)00884838085183(21)F0DDFL
- (01)00884838085183(21)F0DDZD
- (01)00884838085183(21)F0DDZF
Distribution
Distributed nationwide across the United States.
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