CLASS II Device recall · Reported 7 Aug 2019 · FDA Enforcement Report

GE Pristina Serena recalled by GE Healthcare

GE Healthcare is recalling GE Pristina Serena, distributed nationwide in the US. The recall was initiated on 16 May 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial# 738192BU4, 738574BU3, 734192BU8, 733706BU6, 718590BU3, 735558BU9, 738023BU1, 737211BU3, 739178BU2, 733600BU1, 738696BU4, 738793BU9, 738695BU6, 734169BU6, 733707BU4 and 732113BU6

Quantity recalled16

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2132-2019
FDA event ID: 83096
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 16 May 2019
FDA classified: 30 Jul 2019
Reported: 7 Aug 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

16 May 2019	Recall initiated by company
30 Jul 2019	Classified by FDA	+75 days
7 Aug 2019	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.

Product as listed by the FDA

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.

Where it was distributed

Worldwide distribution - US nationwide distribution in the states of AZ, CA, FL, GA, IL, MI, MN, NC, NJ, NY, PA, TX, and VT, and countries of Algeria, Australia, Belgium, Canada, Chile, Columbia, Czech Republic, Finland, France, Germany, Hungary, Iceland, Japan, Korea (Republic of), Kuwait, Lebanon, New Zealand, Norway, Poland, Saudi Arabia, Senegal, South Africa, Sri Lanka, Sweden, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Vietnam.

Nationwide Arizona California Florida Georgia Illinois Michigan Minnesota North Carolina New Jersey New York Pennsylvania Texas Vermont

Questions about this recall

Is GE Pristina Serena recalled?

Yes. GE Healthcare recalled GE Pristina Serena on 16 May 2019. The recall is Class II and its status is Terminated. Recall number Z-2132-2019.

Why was it recalled?

Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.

Which lots are affected?

Serial# 738192BU4, 738574BU3, 734192BU8, 733706BU6, 718590BU3, 735558BU9, 738023BU1, 737211BU3, 739178BU2, 733600BU1, 738696BU4, 738793BU9, 738695BU6, 734169BU6, 733707BU4 and 732113BU6

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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