The Recall Desk
HighFDA (Devices)·Z-2132-2019·Announced 2019-08-07

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.

What this means for you

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
Category
Medical Device — Mammography Accessory
Hazard
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

Distributed nationwide across the United States.

The notice also names 13 states specifically:

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.

See all 2 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

See all →

Same hazard · mechanical failure

See all →