GE Pristina Serena Breast Biopsy Accessory Recalled for Slippage Risk
GE Healthcare is recalling 16 Pristina Serena breast biopsy accessories because the positioner may slip when the machine rotates during a procedure.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where the hazard is mechanical slippage during a procedure, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
GE Healthcare, LLC is recalling 16 units of the Pristina Serena, an optional accessory for the Senographe Pristina mammography system. The device is intended to provide accurate three-dimensional location of breast lesions. The recall was initiated because the biopsy positioner may slip when the gantry is rotated during a biopsy procedure.
The affected units were distributed worldwide, including in the United States and numerous international countries. The specific serial numbers for the recalled units are 738192BU4, 738574BU3, 734192BU8, 733706BU6, 718590BU3, 735558BU9, 738023BU1, 737211BU3, 739178BU2, 733600BU1, 738696BU4, 738793BU9, 738695BU6, 734169BU6, 733707BU4, and 732113BU6.
Healthcare facilities should check their inventory for these specific serial numbers and stop using the affected devices. Users should contact GE Healthcare for instructions on how to resolve the issue.
The recalled product
- Product
- GE Pristina Serena - Product Usage: Pristina Serena is an optional accessory of Senographe Pristina intended to provide accurate location of lesions in the breast in three dimensions.
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 16
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 (15)
- Serial# 738192BU4
- 738574BU3
- 734192BU8
- 733706BU6
- 718590BU3
- 735558BU9
- 738023BU1
- 737211BU3
- 739178BU2
- 733600BU1
- 738696BU4
- 738793BU9
- 738695BU6
- 734169BU6
- 733707BU4 and 732113BU6
Distribution
Part of a larger recall action
This product is one of 2 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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