CLASS II Device recall · Reported 3 Aug 2016 · FDA Enforcement Report

Imagecast Pacs with Centricity Ris-ic versions prior to recalled

Ge Healthcare It is recalling Imagecast Pacs with Centricity Ris-ic versions prior to 6 Update Package 18, distributed nationwide in the US. The recall was initiated on 18 Feb 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesImagecast PACS 3.5.69, 3.5.86, 3.5.87 and 3.6 with Centricity. RIS-IC 10.6 versions prior to update Package 18.

Quantity recalled13

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-2300-2016
FDA event ID: 64758
Recalling firm: Ge Healthcare It, Barrington, IL
Classification: Class II
Status: Terminated
Recall initiated: 18 Feb 2013
FDA classified: 28 Jul 2016
Reported: 3 Aug 2016
Type: N/A
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Imaging Equipment

Timeline

18 Feb 2013	Recall initiated by company
28 Jul 2016	Classified by FDA	+1256 days
3 Aug 2016	Published in enforcement report	+6 days

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

Reason for recall

A software defect was discovered that causes images to be out of context with clinical information.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA.

Where it was distributed

US Nationwide Distribution.

Nationwide

Questions about this recall

Is Imagecast Pacs with Centricity Ris-ic versions prior to 6 Update Package 18 recalled?

Yes. Ge Healthcare It recalled Imagecast Pacs with Centricity Ris-ic versions prior to 6 Update Package 18 on 18 Feb 2013. The recall is Class II and its status is Terminated. Recall number Z-2300-2016.

Why was it recalled?

A software defect was discovered that causes images to be out of context with clinical information.

Which lots are affected?

Imagecast PACS 3.5.69, 3.5.86, 3.5.87 and 3.6 with Centricity. RIS-IC 10.6 versions prior to update Package 18.

Where was it sold?

US Nationwide Distribution.

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.

More recalls from Ge Healthcare It

All 17

Reported	Class	Recall	Company	Reason	Where
14 Sep 2016Device	CLASS II	Centricity Enterprise Archive is recalled by Ge Healthcare It	Ge Healthcare It	Device Malfunction	Nationwide
7 Sep 2016Device	CLASS II	Centricity Laboratory Core Lab System 1 The Centricity recalled	GE Healthcare It	Device Malfunction	Nationwide
24 Aug 2016Device	CLASS II	GE Centricity PACS Workstation recalled by GE Healthcare It	GE Healthcare It	Other	Nationwide
31 Dec 2014Device	CLASS II	Centricity Enterprise Archive is recalled by Ge Healthcare It	Ge Healthcare It	Device Malfunction	Nationwide
5 Feb 2014Device	CLASS III	The Centricity Laboratory System is intended to be recalled	GE Healthcare It	Device Malfunction	Nationwide

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