The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1262-2016·Announced 2016-04-06

Siemens E.CAM Gamma Camera Recall for Collimator Change Instructions

Siemens is recalling 3,090 E.CAM gamma camera systems to provide supplemental instructions and visual aids for proper collimator changes.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the existing manual is correct and the issue is a clarification of instructions. There are no reported injuries or illnesses, fitting the criteria for a moderate risk or voluntary precautionary recall.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 3,090 units of the E.CAM gamma camera system. The E.CAM is a SPECT system used to measure the distribution of radiopharmaceuticals in humans to determine metabolic and physiologic functions. The affected units were distributed worldwide, including in all 50 U.S. states, the District of Columbia, Puerto Rico, and numerous foreign countries.

The recall was initiated following a customer complaint reported via the FDA's MedWatch process. A Hazard Analysis and Corrective and Preventive Action (CAPA) investigation determined that while the existing user manual is correct, additional supplemental instructions with visual aids are needed to further clarify and emphasize the proper procedure for changing collimators.

The recall is intended to ensure that users have the clearest possible guidance for this specific maintenance task. No specific adverse events, injuries, or illnesses are reported in the source text. Users of the affected systems should refer to the supplemental instructions provided by Siemens to ensure proper collimator changes.

The recalled product

Product
The E.CAM gamma camera system Product Usage: The E.CAM gamma camera system is a SPECT system and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body
Manufacturer
Siemens Medical Solutions USA, Inc.
Category
Medical Device — Imaging Equipment
Hazard
Affected units
3,090

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)

  • 10275879
  • 10413009
  • 04380213
  • 04380221
  • 05242826
  • 05977066
  • 05977074
  • 05984005
  • 05989079
  • 05989087
  • 05989095
  • 05991109
  • 05991117
  • 05992099
  • 07324119
  • 07324135
  • 07324143
  • 07324150
  • 07760809
  • 07760932

Distribution

Distributed nationwide across the United States.

The notice also names 52 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Siemens Medical Solutions USA, Inc. 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 · Siemens Medical Solutions USA, Inc.

See all →

Same hazard · improper use

See all →

Similar recalls